Medical device recalls in 2019What FDA recall data shows
Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026
Key findings
- The FDA posted 843 medical device recall records in 2019, from 157 recall events by 118 companies — 8% more than the same period of 2018 (783).
- 360 records (43%) are Class I, the most serious category (same period of 2018: 132).
- The product line named in the most recall records was SHERPA NX ACTIVE (Medtronic, Inc.), with 191.
- GE Healthcare, LLC had the most recall events (10, covering 25 records).
- The most common FDA root-cause category was “Device Design” (30% of records).
Recall records by month
Red = Class I. Click a month for every recall posted that month.
Most-recalled product lines
Product lines whose models are named by device identifier in recall records posted in 2019.
| Product | Company | Recall records | Class I |
|---|---|---|---|
| SHERPA NX ACTIVE | Medtronic, Inc. | 191 | 191 |
| SYNCHRO 2 | Stryker Corporation | 8 | — |
| Natrelle Breast Implants | Allergan, Inc. | 7 | 7 |
| ACCU-CHEK GUIDE | Roche Diagnostics Operations, Inc. | 5 | — |
| CrossCath | Cook Incorporated | 4 | 4 |
| Vitality | Biomet Spine LLC | 3 | — |
| STRATAFIX | Ethicon, LLC | 2 | — |
| MOSAIC | Medtronic, Inc. | 2 | — |
| Electrosurgical Tip Cleaner; PL | Xodus Medical, Inc. | 2 | — |
| Curlin Administration Set | Zevex International, Inc. | 2 | — |
| Chlor-XTRA | Vista Dental | 2 | — |
| Centricity | Ge Healthcare | 2 | — |
Companies with the most recall events
| Company | Events | Records | Class I |
|---|---|---|---|
| GE Healthcare, LLC | 10 | 25 | 6 |
| Edwards Lifesciences, LLC | 5 | 12 | 12 |
| Cook Inc. | 4 | 9 | 8 |
| Boston Scientific Corporation | 3 | 23 | — |
| Teleflex Medical | 3 | 17 | 17 |
| Maquet Cardiovascular Us Sales, Llc | 3 | 15 | 1 |
| Luminex Corporation | 3 | 9 | — |
| Becton Dickinson & Company | 3 | 3 | 2 |
| Philips Medical Systems (Cleveland) Inc | 2 | 14 | 5 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 2 | 9 | 7 |
| Stryker Neurovascular | 2 | 9 | — |
| ICU Medical, Inc. | 2 | 8 | 8 |
Companies that assemble kits or reprocess devices often appear high: when a component is recalled, every kit that contains it gets its own record.
Most-recalled device types
| Device type (FDA product code) | Records | Class I |
|---|---|---|
| Catheter, Percutaneous DQY | 192 | 191 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF | 189 | 6 |
| System, nuclear magnetic resonance imaging LNH | 64 | — |
| Apron, Leaded EAJ | 24 | — |
| Tube, tracheal (w/wo connector) BTR | 17 | 17 |
| Powered Laser Surgical Instrument GEX | 14 | — |
| Lamp, surgical FTD | 13 | — |
| Catheter, Biliary, Diagnostic FGE | 13 | — |
| Nebulizer (Direct Patient Interface) CAF | 13 | 13 |
| System, tomography, computed, emission KPS | 11 | 5 |
| System, x-ray, tomography, computed JAK | 10 | — |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled FTR | 10 | 10 |
Why devices were recalled
| FDA root-cause category | Records | Share |
|---|---|---|
| Device Design | 257 | 30% |
| Component design/selection | 211 | 25% |
| Unknown/Undetermined by firm | 81 | 10% |
| Process control | 80 | 9% |
| Under Investigation by firm | 50 | 6% |
| Other | 30 | 4% |
| Nonconforming Material/Component | 30 | 4% |
| Software design | 16 | 2% |
| Incorrect or no expiration date | 13 | 2% |
| Process design | 11 | 1% |
| Employee error | 11 | 1% |
| Vendor change control | 8 | 1% |
“Under Investigation by firm” means the company had not yet reported a root cause when the record was posted.
All Class I recalls in 2019 (360)
- Z-0020-2020 · Galemed Corporation · posted Dec 20, 2019 · Terminated
- Z-0021-2020 · Galemed Corporation · posted Dec 20, 2019 · Terminated
- Z-0022-2020 · Galemed Corporation · posted Dec 20, 2019 · Terminated
- Z-0561-2020 · LivaNova USA Inc · posted Dec 20, 2019 · Terminated
- Z-0610-2020 · Smiths Medical ASD Inc. · posted Dec 12, 2019 · Terminated
- Z-0587-2020 · Cook Inc. · posted Dec 9, 2019 · Terminated
- Z-0588-2020 · Cook Inc. · posted Dec 9, 2019 · Terminated
- Z-0589-2020 · Cook Inc. · posted Dec 9, 2019 · Terminated
- Z-0590-2020 · Cook Inc. · posted Dec 9, 2019 · Terminated
- Z-0508-2020 · Medtronic Neuromodulation · posted Dec 3, 2019 · Terminated
- Z-0538-2020 · GE Healthcare, LLC · posted Dec 3, 2019 · Terminated
- Z-0539-2020 · GE Healthcare, LLC · posted Dec 3, 2019 · Terminated
- Z-0540-2020 · GE Healthcare, LLC · posted Dec 3, 2019 · Terminated
- Z-0541-2020 · GE Healthcare, LLC · posted Dec 3, 2019 · Terminated
- Z-0009-2020 · Teleflex-Morrisville · posted Nov 7, 2019 · Terminated
- Z-0177-2020 · Medtronic Inc. · posted Nov 4, 2019 · Terminated
- Z-0178-2020 · Medtronic Inc. · posted Nov 4, 2019 · Terminated
- Z-0172-2020 · Medtech Sas · posted Nov 1, 2019 · Terminated
- Z-0213-2020 · Philips Medical Systems (Cleveland) Inc · posted Nov 1, 2019 · Terminated
- Z-0214-2020 · Philips Medical Systems (Cleveland) Inc · posted Nov 1, 2019 · Terminated
- Z-0215-2020 · Philips Medical Systems (Cleveland) Inc · posted Nov 1, 2019 · Terminated
- Z-0216-2020 · Philips Medical Systems (Cleveland) Inc · posted Nov 1, 2019 · Terminated
- Z-0217-2020 · Philips Medical Systems (Cleveland) Inc · posted Nov 1, 2019 · Terminated
- Z-0221-2020 · Thoratec Switzerland GMBH · posted Oct 30, 2019 · Terminated
- Z-0200-2020 · Ethicon Endo-Surgery Inc · posted Oct 29, 2019 · Terminated
- Z-0201-2020 · Ethicon Endo-Surgery Inc · posted Oct 29, 2019 · Terminated
- Z-0202-2020 · Ethicon Endo-Surgery Inc · posted Oct 29, 2019 · Terminated
- Z-0203-2020 · Ethicon Endo-Surgery Inc · posted Oct 29, 2019 · Terminated
- Z-2562-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular useClass IZ-2563-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2564-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular useClass IZ-2565-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2566-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular useClass IZ-2567-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular useClass IZ-2568-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2569-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular useClass IZ-2570-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular useClass IZ-2571-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular useClass IZ-2572-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular useClass IZ-2573-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2574-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular useClass IZ-2575-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular useClass IZ-2576-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular useClass IZ-2577-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular useClass IZ-2578-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular useClass IZ-2579-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular useClass IZ-2580-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2581-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2582-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2583-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2584-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular useClass IZ-2585-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular useClass IZ-2586-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular useClass IZ-2587-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular useClass IZ-2588-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular useClass IZ-2589-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular useClass IZ-2590-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular useClass IZ-2591-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular useClass IZ-2592-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular useClass IZ-2593-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular useClass IZ-2594-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular useClass IZ-2595-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2596-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2597-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2598-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular useClass IZ-2599-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular useClass IZ-2600-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2601-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular useClass IZ-2602-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2603-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2604-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular useClass IZ-2605-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2606-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular useClass IZ-2607-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular useClass IZ-2608-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular useClass IZ-2609-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2610-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2611-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular useClass IZ-2612-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2613-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2614-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2615-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2616-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2617-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2618-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2619-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2620-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2621-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2622-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2623-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2624-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2625-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular useClass IZ-2626-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2627-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2628-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular useClass IZ-2629-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2630-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2631-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2632-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2633-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2634-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2635-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2636-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular useClass IZ-2637-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2638-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2639-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2640-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2641-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2642-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2643-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2644-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2645-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2646-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2647-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2648-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. for cardiovascular useClass IZ-2649-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2650-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2651-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2652-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2653-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for cardiovascular useClass IZ-2654-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular useClass IZ-2655-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular useClass IZ-2656-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2657-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2658-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2659-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2660-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2661-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2662-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2663-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2664-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2665-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. for cardiovascular useClass IZ-2666-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2667-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular useClass IZ-2668-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2669-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2670-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2671-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2672-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2673-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2674-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2675-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular useClass IZ-2676-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2677-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2678-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2679-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2680-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2681-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2682-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2683-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2684-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2685-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2686-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2687-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2688-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascular useClass IZ-2689-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2690-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular useClass IZ-2691-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular useClass IZ-2692-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for cardiovascular useClass IZ-2693-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular useClass IZ-2694-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular useClass IZ-2695-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2696-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2697-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for cardiovascular useClass IZ-2698-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular useClass IZ-2699-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2700-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular useClass IZ-2701-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2702-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2703-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2704-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular useClass IZ-2705-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2706-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2707-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular useClass IZ-2708-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular useClass IZ-2709-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular useClass IZ-2710-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2711-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2712-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2713-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular useClass IZ-2714-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2715-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2716-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2717-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2718-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2719-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2720-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2721-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2722-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular useClass IZ-2723-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular useClass IZ-2724-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular useClass IZ-2725-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2726-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular useClass IZ-2727-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2728-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular useClass IZ-2729-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2730-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2731-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular useClass IZ-2732-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2733-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2734-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2735-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2736-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular useClass IZ-2737-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular useClass IZ-2738-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2739-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular useClass IZ-2740-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2741-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2742-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular useClass IZ-2743-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2744-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2745-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2746-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular useClass IZ-2747-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular useClass IZ-2748-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular useClass IZ-2749-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2750-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2751-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2752-2019 · Medtronic Vascular · posted Oct 1, 2019 · Terminated
- Z-2489-2019 · B. Braun Medical, Inc. · posted Sep 23, 2019 · Terminated
- Z-2451-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2452-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2453-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2454-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2455-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2456-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2457-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2458-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2459-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2460-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2461-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2462-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM ↗Class IZ-2463-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM ↗Class IZ-2464-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Z-2465-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
- Hudson RCI Sheridan LTS:Class IZ-2311-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Hudson RCI Sheridan/CF:Class IZ-2312-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Hudson RCI Sheridan EZ-ENDO:Class IZ-2313-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Z-2314-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Z-2315-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Hudson RCI Sheridan/HVT:Class IZ-2316-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Z-2317-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Sheridan/HVT Novaplus:Class IZ-2318-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
- Quantum Pump ConsoleClass IZ-2238-2019 · Spectrum Medical Ltd. · posted Aug 23, 2019 · Terminated
- Z-2224-2019 · Edwards Lifesciences, LLC · posted Aug 21, 2019 · Terminated
- Z-2225-2019 · Edwards Lifesciences, LLC · posted Aug 21, 2019 · Terminated
- Z-2226-2019 · Edwards Lifesciences, LLC · posted Aug 21, 2019 · Terminated
- Z-2227-2019 · Edwards Lifesciences, LLC · posted Aug 21, 2019 · Terminated
- Z-2064-2019 · Fenwal Inc · posted Aug 12, 2019 · Terminated
- Z-2065-2019 · Fenwal Inc · posted Aug 12, 2019 · Terminated
- Z-2066-2019 · Medline Industries Inc · posted Aug 12, 2019 · Terminated
- Z-2067-2019 · Medline Industries Inc · posted Aug 12, 2019 · Terminated
- Z-2070-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- Z-2071-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 ↗Class IZ-2072-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- Z-2073-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 ↗Class IZ-2074-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 ↗Class IZ-2075-2019 · St Jude Medical Inc. · posted Aug 2, 2019 · Terminated
- Z-2088-2019 · Qiagen Sciences LLC · posted Aug 1, 2019 · Terminated
- Z-1956-2019 · Centurion Medical Products Corporation · posted Jul 30, 2019 · Terminated
- Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin.Class IZ-1768-2019 · CareFusion 303, Inc. · posted Jul 16, 2019 · Terminated
- Z-1939-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1940-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1941-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1942-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1943-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1944-2019 · Datascope Corp. · posted Jul 16, 2019 · Open, Classified
- Z-1912-2019 · Teleflex Medical · posted Jul 15, 2019 · Terminated
- Z-1770-2019 · Becton Dickinson & Company · posted Jul 11, 2019 · Terminated
- Z-1846-2019 · GE Healthcare, LLC · posted Jul 11, 2019 · Terminated
- Panda Infant Radiant WarmerClass IZ-1847-2019 · GE Healthcare, LLC · posted Jul 11, 2019 · Terminated
- Z-1874-2019 · Hamilton Medical AG · posted Jul 11, 2019 · Terminated
- Z-1210-2019 · Becton Dickinson & Company · posted Jun 26, 2019 · Terminated
- enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.Class IZ-1385-2019 · Vyaire Medical · posted Jun 26, 2019 · Terminated
- Z-1386-2019 · Vyaire Medical · posted Jun 26, 2019 · Terminated
- Z-1759-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Hudson RCI Sheridan:Class IZ-1760-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Hudson RCI Sheridan:Class IZ-1761-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Hudson RCI Sheridan:Class IZ-1762-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Hudson RCI Sheridan:Class IZ-1763-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Hudson RCI Sheridan:Class IZ-1764-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Z-1765-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Sheridan/HVT:Class IZ-1766-2019 · Teleflex Medical · posted Jun 19, 2019 · Terminated
- Z-1756-2019 · Cook Inc. · posted Jun 17, 2019 · Terminated
- Z-1757-2019 · Cook Inc. · posted Jun 17, 2019 · Terminated
- Z-1758-2019 · Cook Inc. · posted Jun 17, 2019 · Terminated
- Z-1705-2019 · Edwards Lifesciences, LLC · posted Jun 11, 2019 · Terminated
- Z-1227-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1228-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1229-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1230-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1231-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1232-2019 · OriGen Biomedical, Inc. · posted Jun 4, 2019 · Terminated
- Z-1374-2019 · Terumo Medical Corporation · posted May 28, 2019 · Terminated
- Z-1375-2019 · Terumo Medical Corporation · posted May 28, 2019 · Terminated
- Z-1376-2019 · Terumo Medical Corporation · posted May 28, 2019 · Terminated
- Z-1382-2019 · Beckman Coulter Inc. · posted May 23, 2019 · Terminated
- Z-1383-2019 · Beckman Coulter Inc. · posted May 23, 2019 · Terminated
- Z-1384-2019 · Beckman Coulter Inc. · posted May 23, 2019 · Terminated
- Z-1193-2019 · Edwards Lifesciences, LLC · posted May 21, 2019 · Terminated
- Z-1310-2019 · Integra LifeSciences Corp. · posted May 20, 2019 · Terminated
- Z-1311-2019 · Integra LifeSciences Corp. · posted May 20, 2019 · Terminated
- Z-1312-2019 · Integra LifeSciences Corp. · posted May 20, 2019 · Terminated
- Z-1216-2019 · Alpha Omega Engineering · posted May 6, 2019 · Terminated
- Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F ↗Class IZ-1116-2019 · Edwards Lifesciences, LLC · posted Apr 25, 2019 · Terminated
- Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F ↗Class IZ-1117-2019 · Edwards Lifesciences, LLC · posted Apr 25, 2019 · Terminated
- Z-1082-2019 · Brainlab AG · posted Apr 15, 2019 · Terminated
- Z-1092-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-1093-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-1094-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-1095-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- icumedical ChemoLock, 20mm,Class IZ-1096-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-1097-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-1098-2019 · ICU Medical, Inc. · posted Apr 15, 2019 · Terminated
- Z-0976-2019 · O-Two Medical Technologies, Inc. · posted Apr 4, 2019 · Terminated
- Z-0977-2019 · O-Two Medical Technologies, Inc. · posted Apr 4, 2019 · Terminated
- Z-0978-2019 · O-Two Medical Technologies, Inc. · posted Apr 4, 2019 · Terminated
- Z-0986-2019 · Maquet Cardiovascular Us Sales, Llc · posted Mar 28, 2019 · Terminated
- Z-0979-2019 · Cook Inc. · posted Mar 13, 2019 · Terminated
- Z-0865-2019 · Rvo 2.0, Inc · posted Mar 5, 2019 · Terminated
- Z-0862-2019 · Physio-Control Inc · posted Feb 26, 2019 · Terminated
- Z-0863-2019 · Physio-Control Inc · posted Feb 26, 2019 · Terminated
- Z-0805-2019 · ICU Medical, Inc. · posted Feb 22, 2019 · Terminated
- Z-0806-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0807-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0808-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0809-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0810-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0811-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0812-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
- Z-0710-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0711-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0712-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0713-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0714-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0715-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0716-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0717-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0718-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0719-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0720-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0721-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- Z-0722-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
- CoaguChek XS PT Test ↗Class IZ-0787-2019 · Terrific Care LLC · posted Feb 1, 2019 · Terminated
- Z-0762-2019 · Edwards Lifesciences, LLC · posted Jan 31, 2019 · Terminated
- Z-0763-2019 · Edwards Lifesciences, LLC · posted Jan 31, 2019 · Terminated
- Z-0764-2019 · Edwards Lifesciences, LLC · posted Jan 31, 2019 · Terminated
- Z-0765-2019 · Edwards Lifesciences, LLC · posted Jan 31, 2019 · Terminated
- Z-0767-2019 · West Pharma. Services Il, Ltd · posted Jan 28, 2019 · Terminated
- Z-0768-2019 · West Pharma. Services Il, Ltd · posted Jan 28, 2019 · Terminated
- Z-0769-2019 · West Pharma. Services Il, Ltd · posted Jan 28, 2019 · Terminated
- Z-0736-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0737-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0738-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0739-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0740-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0741-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0742-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0743-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
- Z-0744-2019 · Draeger Medical, Inc. · posted Jan 24, 2019 · Terminated
About this data
- Unit: a recall record is one product in an FDA recall (one recall number, e.g. Z-1234-2019). A recall event can include several products.
- Date: records are counted by the date the FDA posted them, not the date the company started the recall.
- Class: from FDA enforcement reports. Records without a class have not been classified yet.
- Limits: recall counts do not measure how safe a device or company is. Companies with many products, kits or proactive quality systems can have more recalls. How recalls work.
- Sources: FDA Medical Device Recalls database and FDA enforcement reports, via openFDA. Methodology.
Citing this report: “Device Safety Index, Medical Device Recalls in 2019, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.