Medical device recalls in 2020What FDA recall data shows

Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026

Key findings

The FDA posted 839 medical device recall records in 2020, from 227 recall events by 142 companies — about the same as the same period of 2019 (843).
171 records (20%) are Class I, the most serious category (same period of 2019: 360).
The product line named in the most recall records was ALTERA (Globus Medical, Inc.), with 21.
GE Healthcare, LLC had the most recall events (11, covering 25 records).
The most common FDA root-cause category was “Device Design” (18% of records).

Recall records by month

136Jan 157Feb 50Mar 118Apr 68May 57Jun 74Jul 88Aug 19Sep 21Oct 10Nov 41Dec

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 2020.

Product	Company	Recall records	Class I
ALTERA	Globus Medical, Inc.	21	—
STAGEONE	Biomet Orthopedics, LLC	17	—
StageOne Select	Biomet Orthopedics, LLC	15	—
NobelReplace	Nobel Biocare AB	13	—
NC TREK	Abbott Vascular Inc.	12	12
LANGSTON	Teleflex Incorporated	5	5
Port Access Kit	Bard Access Systems, Inc.	4	—
HUDSON RCI	Teleflex Incorporated	4	4
STRATAFIX	Ethicon, LLC	3	—
Port Access Needle	Bard Access Systems, Inc.	3	—
Synchron	Beckman Coulter, Inc.	2	—
SnapLink	Ormco Corporation	2	—

Companies with the most recall events

Company	Events	Records	Class I
GE Healthcare, LLC	11	25	9
Siemens Medical Solutions USA, Inc	10	15	—
Siemens Healthcare Diagnostics, Inc.	9	20	—
CareFusion 303, Inc.	7	23	18
Beckman Coulter Inc.	5	12	—
Philips North America, LLC	5	8	—
Biomet, Inc.	4	51	—
Cook Inc.	4	25	22
Boston Scientific Corporation	4	5	1
Theralase Inc.	4	4	—
CME America, LLC	3	39	39
Covidien Llc	3	31	—

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
Gown, Surgical FYA	39	—
Set, administration, intravascular FPA	38	37
Anesthesia conduction kit CAZ	36	—
Pump, infusion FRN	31	26
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM	28	—
Introducer, Catheter DYB	28	22
System, Balloon, Intra-Aortic And Control DSP	27	10
Awl HWJ	24	—
Intervertebral fusion device with bone graft, lumbar MAX	22	—
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented KWY	20	—
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH	19	—
Catheters, transluminal coronary angioplasty, percutaneous LOX	17	17

Why devices were recalled

FDA root-cause category	Records	Share
Device Design	155	18%
Process control	146	17%
Other	60	7%
Software design	58	7%
Under Investigation by firm	57	7%
Vendor change control	52	6%
Nonconforming Material/Component	52	6%
Process change control	42	5%
Packaging	30	4%
Equipment maintenance	28	3%
Packaging process control	26	3%
Component change control	15	2%

“Under Investigation by firm” means the company had not yet reported a root cause when the record was posted.

All Class I recalls in 2020 (171)

Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 ↗Class I
Z-0591-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 ↗Class I
Z-0592-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 ↗Class I
Z-0593-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 ↗Class I
Z-0594-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 ↗Class I
Z-0595-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 ↗Class I
Z-0596-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 ↗Class I
Z-0597-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 ↗Class I
Z-0598-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 ↗Class I
Z-0599-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 ↗Class I
Z-0600-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 ↗Class I
Z-0601-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 ↗Class I
Z-0602-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 ↗Class I
Z-0603-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 ↗Class I
Z-0604-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 ↗Class I
Z-0605-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 ↗Class I
Z-0606-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 ↗Class I
Z-0607-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 ↗Class I
Z-0608-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 ↗Class I
Z-0609-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 ↗Class I
Z-0610-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 ↗Class I
Z-0611-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0,… ↗Class I
Z-0497-2021 · Flexicare Medical Ltd. · posted Nov 26, 2020 · Terminated
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating…Class I
Z-0399-2021 · Cook Inc. · posted Nov 3, 2020 · Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)Class I
Z-0120-2021 · Baxter Healthcare Corporation · posted Oct 22, 2020 · Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Class I
Z-0121-2021 · Baxter Healthcare Corporation · posted Oct 22, 2020 · Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Class I
Z-0122-2021 · Baxter Healthcare Corporation · posted Oct 22, 2020 · Terminated
Spectrum IQ Infusion System with Dose IQ Safety SoftwareClass I
Z-0123-2021 · Baxter Healthcare Corporation · posted Oct 22, 2020 · Terminated
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM) ↗Class I
Z-0114-2021 · Stryker Neurovascular · posted Oct 21, 2020 · Terminated
Langston Dual Lumen CatheterClass I
Z-0110-2021 · Vascular Solutions, Inc. · posted Oct 20, 2020 · Terminated
Langston Dual Lumen Catheter.Class I
Z-0111-2021 · Vascular Solutions, Inc. · posted Oct 20, 2020 · Terminated
Langston Dual Lumen Catheter.Class I
Z-0112-2021 · Vascular Solutions, Inc. · posted Oct 20, 2020 · Terminated
Langston Dual Lumen Catheter.Class I
Z-0113-2021 · Vascular Solutions, Inc. · posted Oct 20, 2020 · Terminated
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen ↗Class I
Z-0087-2021 · Medtronic Vascular · posted Oct 16, 2020 · Terminated
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen ↗Class I
Z-0088-2021 · Medtronic Vascular · posted Oct 16, 2020 · Terminated
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen ↗Class I
Z-0089-2021 · Medtronic Vascular · posted Oct 16, 2020 · Terminated
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264.… ↗Class I
Z-2941-2020 · MicroPort Orthopedics Inc. · posted Sep 18, 2020 · Terminated
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component ↗Class I
Z-2942-2020 · MicroPort Orthopedics Inc. · posted Sep 18, 2020 · Terminated
BD Alaris SystemClass I
Z-2882-2020 · CareFusion 303, Inc. · posted Sep 4, 2020 · Open, Classified
Alaris System PC Unit Model 8015Class I
Z-2909-2020 · CareFusion 303, Inc. · posted Sep 4, 2020 · Open, Classified
PC Unit Front Case with Keypad Replacement Kits:Class I
Z-2910-2020 · CareFusion 303, Inc. · posted Sep 4, 2020 · Open, Classified
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring systemClass I
Z-2716-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring systemClass I
Z-2717-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris Pump Module Model 8100, a modular infusion pump and monitoring systemClass I
Z-2718-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring systemClass I
Z-2719-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris PCA Module Model 8120, a modular infusion pump and monitoring systemClass I
Z-2720-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring systemClass I
Z-2721-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring systemClass I
Z-2722-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring systemClass I
Z-2723-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Medfusion Syringe Pump Model 4000Class I
Z-2734-2020 · Smiths Medical ASD Inc. · posted Aug 6, 2020 · Open, Classified
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.Class I
Z-2735-2020 · Smiths Medical ASD Inc. · posted Aug 6, 2020 · Open, Classified
Alaris Pump Module Model 8100Class I
Z-2736-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris System PC Unit Model 8000 modular infusion pump and monitoring systemClass I
Z-2740-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
Alaris System PC Unit Model 8015. modular infusion pump and monitoring systemClass I
Z-2741-2020 · CareFusion 303, Inc. · posted Aug 6, 2020 · Terminated
BodyGuard BodySet, REF: A120-160SAS ↗Class I
Z-2553-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-160XPS ↗Class I
Z-2554-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A100-163XESV ↗Class I
Z-2555-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A100-163XES ↗Class I
Z-2556-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-161XPS ↗Class I
Z-2557-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-160XSFK ↗Class I
Z-2558-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-112XSFK ↗Class I
Z-2559-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A100-163XSFL ↗Class I
Z-2560-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-160XYSF ↗Class I
Z-2561-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-161XYB ↗Class I
Z-2562-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-161XYBS ↗Class I
Z-2563-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Filter, REF: A100-163XESF ↗Class I
Z-2564-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-161XPSV ↗Class I
Z-2565-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-160X2YB ↗Class I
Z-2566-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY ↗Class I
Z-2567-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Set, REF: A120-160CRV ↗Class I
Z-2568-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Set, REF: A120-161CYF ↗Class I
Z-2569-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS ↗Class I
Z-2570-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Filter, REF: A120-160XSFE ↗Class I
Z-2571-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Filter, REF: A100-164XESF ↗Class I
Z-2572-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A100-163XE90S ↗Class I
Z-2573-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A100-163XSL ↗Class I
Z-2574-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-003XS2YV ↗Class I
Z-2575-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-125XSE ↗Class I
Z-2576-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset, REF: A120-160GCFA ↗Class I
Z-2577-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Sets, REF: A120-160CYFRV ↗Class I
Z-2578-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Sets, REF: A120-160C2YRV ↗Class I
Z-2579-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Sets, REF: A120-161C ↗Class I
Z-2580-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF ↗Class I
Z-2581-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard set with Female Luer, REF: A120-003XSN ↗Class I
Z-2582-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV ↗Class I
Z-2583-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF ↗Class I
Z-2584-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Standard BodySet with Needleless Connectors, REF: A120-125XS ↗Class I
Z-2585-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Microbore Set, REF: A120-160C ↗Class I
Z-2586-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK ↗Class I
Z-2587-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset With Female Luer, REF: A120-160XPSN ↗Class I
Z-2588-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV ↗Class I
Z-2589-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System ↗Class I
Z-2476-2020 · Verathon, Inc. · posted Jul 10, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400Class I
Z-2408-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400EClass I
Z-2409-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500Class I
Z-2410-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500EClass I
Z-2411-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500IClass I
Z-2412-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500JClass I
Z-2413-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NLClass I
Z-2414-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535Class I
Z-2415-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700 ↗Class I
Z-2416-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701 ↗Class I
Z-2417-2020 · Arrow International Inc · posted Jun 26, 2020 · Terminated
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I,…Class I
Z-2263-2020 · Endologix, Inc. · posted Jun 11, 2020 · Terminated
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the…Class I
Z-2039-2020 · Medtronic Vascular Galway DBA Medtronic Ireland · posted May 27, 2020 · Terminated
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation…Class I
Z-1995-2020 · Medtronic Navigation, Inc. · posted May 18, 2020 · Terminated
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly…Class I
Z-1791-2020 · Argon Medical Devices, Inc · posted May 7, 2020 · Terminated
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074.…Class I
Z-1792-2020 · Argon Medical Devices, Inc · posted May 7, 2020 · Terminated
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI:Class I
Z-1846-2020 · Applied Medical Resources Corp · posted May 7, 2020 · Terminated
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI:Class I
Z-1847-2020 · Applied Medical Resources Corp · posted May 7, 2020 · Terminated
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile… ↗Class I
Z-1848-2020 · Applied Medical Resources Corp · posted May 7, 2020 · Terminated
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studiesClass I
Z-1747-2020 · Vascular Solutions, Inc. · posted Apr 27, 2020 · Terminated
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88.Class I
Z-1567-2020 · LeMaitre Vascular, Inc. · posted Apr 1, 2020 · Open, Classified
Imager II 5F Angiographic Catheters, 5 units per package. ↗Class I
Z-1555-2020 · Boston Scientific Corporation · posted Mar 25, 2020 · Open, Classified
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and… ↗Class I
Z-1474-2020 · CME America, LLC · posted Mar 18, 2020 · Terminated
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8mlClass I
Z-1442-2020 · CME America, LLC · posted Mar 11, 2020 · Terminated
HeartWare HVAD System Battery ChargerClass I
Z-1427-2020 · Heartware, Inc. · posted Mar 9, 2020 · Open, Classified
HeartWare HVAD System Battery Charger AC AdapterClass I
Z-1428-2020 · Heartware, Inc. · posted Mar 9, 2020 · Open, Classified
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.Class I
Z-1527-2020 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · posted Mar 9, 2020 · Terminated
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use. ↗Class I
Z-1528-2020 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · posted Mar 9, 2020 · Terminated
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)Class I
Z-1359-2020 · CareFusion 303, Inc. · posted Mar 5, 2020 · Open, Classified
CareFusion Alaris Pump Module, Model 8100Class I
Z-1360-2020 · CareFusion 303, Inc. · posted Mar 5, 2020 · Open, Classified
CareFusion Alaris Syringe Module, Model 8110Class I
Z-1361-2020 · CareFusion 303, Inc. · posted Mar 5, 2020 · Open, Classified
CareFusion Alaris PCA Module, Model 8120Class I
Z-1362-2020 · CareFusion 303, Inc. · posted Mar 5, 2020 · Open, Classified
Trilogy EVO Ventilator, International, Model Number IN2110X15B ↗Class I
Z-0942-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B ↗Class I
Z-0943-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B ↗Class I
Z-0944-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B ↗Class I
Z-0945-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B ↗Class I
Z-0946-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B ↗Class I
Z-0947-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B ↗Class I
Z-0948-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, France - Model Number: FR2110X14B ↗Class I
Z-0949-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B ↗Class I
Z-0950-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B ↗Class I
Z-0951-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B ↗Class I
Z-0952-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B ↗Class I
Z-0953-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B ↗Class I
Z-0954-2020 · Philips Respironics, Inc. · posted Feb 15, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDCClass I
Z-1128-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDCClass I
Z-1129-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDCClass I
Z-1130-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDCClass I
Z-1131-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDCClass I
Z-1132-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDCClass I
Z-1133-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDCClass I
Z-1134-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDCClass I
Z-1135-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDCClass I
Z-1136-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDCClass I
Z-1137-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDCClass I
Z-1138-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDCClass I
Z-1139-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM ↗Class I
Z-1140-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM ↗Class I
Z-1141-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM ↗Class I
Z-1142-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM ↗Class I
Z-1143-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM ↗Class I
Z-1144-2020 · Abbott Vascular · posted Feb 14, 2020 · Terminated
PneumoDart, 14 ga x 3.25in., REF TM-317 ↗Class I
Z-0930-2020 · Tytek Medical Inc · posted Feb 12, 2020 · Terminated
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755Class I
Z-0955-2020 · Medtronic Inc. · posted Feb 7, 2020 · Open, Classified
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761,…Class I
Z-0956-2020 · Medtronic Inc. · posted Feb 7, 2020 · Open, Classified
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 ↗Class I
Z-0957-2020 · Medtronic Inc. · posted Feb 7, 2020 · Open, Classified
Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751,… ↗Class I
Z-0958-2020 · Medtronic Inc. · posted Feb 7, 2020 · Open, Classified
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kitClass I
Z-1112-2020 · Teleflex Medical Inc · posted Feb 7, 2020 · Terminated
HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kitClass I
Z-1113-2020 · Teleflex Medical Inc · posted Feb 7, 2020 · Terminated
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kitClass I
Z-1114-2020 · Teleflex Medical Inc · posted Feb 7, 2020 · Terminated
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kitClass I
Z-1115-2020 · Teleflex Medical Inc · posted Feb 7, 2020 · Terminated
King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in… ↗Class I
Z-0916-2020 · King Systems Corp. dba Ambu, Inc. · posted Feb 4, 2020 · Terminated
Carestation 620/650/650c A1Class I
Z-0813-2020 · GE Healthcare, LLC · posted Jan 23, 2020 · Terminated
Carestation 620/650/650c A2 ↗Class I
Z-0814-2020 · GE Healthcare, LLC · posted Jan 23, 2020 · Terminated
CARESCAPE Respiratory Module E-sCO ↗Class I
Z-0754-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
CARESCAPE Respiratory Module E-sCOVX ↗Class I
Z-0755-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
CARESCAPE Respiratory Module E-sCAiO ↗Class I
Z-0756-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
CARESCAPE Respiratory Module E-sCAiOV ↗Class I
Z-0757-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
CARESCAPE Respiratory Module E-sCAiOE ↗Class I
Z-0758-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
CARESCAPE Respiratory Module E-sCAiOVE ↗Class I
Z-0759-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated
Airway Gas Option N-CAiO ↗Class I
Z-0760-2020 · GE Healthcare, LLC · posted Jan 10, 2020 · Terminated

About this data

Unit: a recall record is one product in an FDA recall (one recall number, e.g. Z-1234-2020). 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 2020, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.