Medical device recalls in 2021What FDA recall data shows
Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026
Key findings
- The FDA posted 366 medical device recall records in 2021, from 115 recall events by 84 companies — 56% fewer than the same period of 2020 (839).
- 118 records (32%) are Class I, the most serious category (same period of 2020: 171).
- The product line named in the most recall records was Novation (Exactech, Inc.), with 18.
- GE Healthcare, LLC had the most recall events (10, covering 35 records).
- The most common FDA root-cause category was “Device Design” (23% 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 2021.
| Product | Company | Recall records | Class I |
|---|---|---|---|
| Novation | Exactech, Inc. | 18 | — |
| Puritan Bennett | Covidien LP | 15 | 15 |
| Acumatch A Series | Exactech, Inc. | 9 | — |
| SureStep Foley Tray System Bardex IC Complete Care | C. R. Bard, Inc. | 5 | — |
| Alinity m | Abbott Molecular Inc. | 5 | 5 |
| PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 4 | — |
| Penumbra System | Penumbra, Inc. | 4 | 4 |
| SureStep Foley Tray System Bard Lubricath Foley | C. R. Bard, Inc. | 3 | — |
| PRECICE Trauma Nail System | Nuvasive Specialized Orthopedics, Inc. | 3 | — |
| PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 3 | — |
| PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 3 | — |
| NMCT | G E Medical Systems Israel Ltd. | 3 | — |
Companies with the most recall events
| Company | Events | Records | Class I |
|---|---|---|---|
| GE Healthcare, LLC | 10 | 35 | — |
| Boston Scientific Corporation | 6 | 23 | 15 |
| Datascope Corp. | 4 | 7 | 3 |
| Exactech, Inc. | 3 | 33 | — |
| Smiths Medical ASD Inc. | 3 | 14 | 2 |
| Philips North America Llc | 3 | 7 | — |
| Fresenius Medical Care Holdings, Inc. | 2 | 30 | — |
| Nuvasive Specialized Orthopedics Inc | 2 | 6 | — |
| Philips Respironics, Inc. | 2 | 6 | 6 |
| Arrow International Inc | 2 | 5 | 4 |
| Siemens Medical Solutions USA, Inc | 2 | 4 | — |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 2 | 3 | 2 |
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
Why devices were recalled
| FDA root-cause category | Records | Share |
|---|---|---|
| Device Design | 84 | 23% |
| Process control | 46 | 13% |
| Under Investigation by firm | 43 | 12% |
| Software design | 41 | 11% |
| Unknown/Undetermined by firm | 26 | 7% |
| Vendor change control | 21 | 6% |
| Packaging change control | 21 | 6% |
| Nonconforming Material/Component | 17 | 5% |
| Reprocessing Controls | 16 | 4% |
| Component design/selection | 8 | 2% |
| Package design/selection | 6 | 2% |
| Process design | 5 | 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 2021 (118)
- Z-0336-2022 · Datascope Corp. · posted Dec 30, 2021 · Open, Classified
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
- Z-0337-2022 · Datascope Corp. · posted Dec 30, 2021 · Open, Classified
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
- Z-0394-2022 · Cardiovascular Systems Inc · posted Dec 21, 2021 · Terminated
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for…
- Z-0338-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0339-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0340-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0341-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0342-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0343-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0344-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0345-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0346-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0347-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0348-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0349-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0350-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0351-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0352-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0353-2022 · Covidien Llc · posted Dec 9, 2021 · Terminated
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Z-0231-2022 · Arrow International Inc · posted Nov 18, 2021 · Terminated
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Z-0232-2022 · Arrow International Inc · posted Nov 18, 2021 · Terminated
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Z-0233-2022 · Arrow International Inc · posted Nov 18, 2021 · Terminated
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Z-0234-2022 · Arrow International Inc · posted Nov 18, 2021 · Terminated
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Z-0194-2022 · Lumenis, Inc. · posted Nov 4, 2021 · Terminated
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
- Z-0091-2022 · Datascope Corp. · posted Oct 20, 2021 · Open, Classified
A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
- Z-0107-2022 · Smiths Medical ASD Inc. · posted Oct 19, 2021 · Terminated
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
- Z-0004-2022 · Abbott Molecular, Inc. · posted Oct 14, 2021 · Terminated
There is a potential for false positive results.
- Z-0005-2022 · Abbott Molecular, Inc. · posted Oct 14, 2021 · Terminated
There is a potential for false positive results.
- Z-0006-2022 · Abbott Molecular, Inc. · posted Oct 14, 2021 · Terminated
There is a potential for false positive results.
- Z-0007-2022 · Abbott Molecular, Inc. · posted Oct 14, 2021 · Terminated
There is a potential for false positive results.
- Z-0008-2022 · Abbott Molecular, Inc. · posted Oct 14, 2021 · Terminated
There is a potential for false positive results.
- Z-2499-2021 · Deroyal Industries, Inc. Lafollette · posted Sep 29, 2021 · Terminated
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
- Z-2577-2021 · Imperative Care Inc · posted Sep 29, 2021 · Completed
There is a potential for distal end of catheters to fracture and become detached.
- Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB ↗Class IZ-2428-2021 · Cordis Corporation · posted Sep 15, 2021 · Terminated
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or…
- Z-2429-2021 · Cordis Corporation · posted Sep 15, 2021 · Terminated
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or…
- Z-2430-2021 · Cordis Corporation · posted Sep 15, 2021 · Terminated
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or…
- Z-2431-2021 · Cordis Corporation · posted Sep 15, 2021 · Terminated
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or…
- Z-2432-2021 · Cordis Corporation · posted Sep 15, 2021 · Terminated
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or…
- Z-2433-2021 · Armstrong Medical Services Limited · posted Sep 13, 2021 · Terminated
Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which could cause a delay in treatment. Not all defective canisters will be…
- Z-2391-2021 · Athena Medical Products Inc · posted Sep 9, 2021 · Terminated
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
- Z-2392-2021 · Athena Medical Products Inc · posted Sep 9, 2021 · Terminated
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
- Z-2244-2021 · Cardinal Health 200, LLC · posted Aug 13, 2021 · Terminated
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed…
- Z-2165-2021 · Baxter Healthcare Corporation · posted Aug 11, 2021 · Terminated
Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
- Z-2110-2021 · Baxter Healthcare Corporation · posted Aug 6, 2021 · Terminated
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
- Z-2204-2021 · BioMedical Equipment Service Co (BMES) · posted Aug 6, 2021 · Terminated
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free…
- Z-1956-2021 · Philips Respironics, Inc. · posted Jul 15, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-1957-2021 · Philips Respironics, Inc. · posted Jul 15, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-1958-2021 · Philips Respironics, Inc. · posted Jul 15, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-1972-2021 · Philips Respironics, Inc. · posted Jul 13, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-1973-2021 · Philips Respironics, Inc. · posted Jul 13, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-1974-2021 · Philips Respironics, Inc. · posted Jul 13, 2021 · Open, Classified
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Z-2015-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- Z-2016-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- Z-2017-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- INVIVE CRT-P, Model Numbers:Class IZ-2018-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- INTUA CRT-P, Model Numbers:Class IZ-2019-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- Z-2020-2021 · Boston Scientific Corporation · posted Jul 13, 2021 · Open, Classified
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal…
- Z-1952-2021 · Magellan Diagnostics, Inc. · posted Jul 1, 2021 · Terminated
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- Z-1953-2021 · Magellan Diagnostics, Inc. · posted Jul 1, 2021 · Terminated
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- Z-1954-2021 · Magellan Diagnostics, Inc. · posted Jul 1, 2021 · Terminated
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- Z-1928-2021 · Quidel Corporation · posted Jun 26, 2021 · Terminated
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely…
- GENOSYL DS ↗Class IZ-1863-2021 · Vero Biotech, LLC · posted Jun 23, 2021 · Terminated
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
- Z-1860-2021 · Medtronic Vascular · posted Jun 16, 2021 · Terminated
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
- Z-1798-2021 · Smiths Medical ASD Inc. · posted Jun 10, 2021 · Terminated
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
- Z-1832-2021 · DeRoyal Industries Inc · posted Jun 10, 2021 · Terminated
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
- Z-1833-2021 · DeRoyal Industries Inc · posted Jun 10, 2021 · Terminated
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
- Z-1834-2021 · DeRoyal Industries Inc · posted Jun 10, 2021 · Terminated
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
- Z-1784-2021 · Avid Medical, Inc. · posted Jun 4, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach…
- Z-1785-2021 · Avid Medical, Inc. · posted Jun 4, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach…
- FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03Class IZ-1786-2021 · Avid Medical, Inc. · posted Jun 4, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach…
- Z-1787-2021 · Avid Medical, Inc. · posted Jun 4, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach…
- Z-1554-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1555-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1556-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1557-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1558-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1559-2021 · Medical Action Industries, Inc. 306 · posted May 12, 2021 · Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
- Z-1543-2021 · Step-Har Medical LLC · posted May 10, 2021 · Terminated
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free…
- Z-1530-2021 · St. Jude Medical, Cardian Rhythm Management Division · posted May 7, 2021 · Open, Classified
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
- Z-1531-2021 · St. Jude Medical, Cardian Rhythm Management Division · posted May 7, 2021 · Open, Classified
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
- Z-1331-2021 · Tenacore LLC · posted Apr 2, 2021 · Terminated
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free…
- Z-1332-2021 · Tenacore LLC · posted Apr 2, 2021 · Terminated
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free…
- Z-1305-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Mar 27, 2021 · Open, Classified
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
- Z-1306-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Mar 27, 2021 · Open, Classified
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
- Z-1258-2021 · Smisson-Cartledge Biomedical, LLC · posted Mar 26, 2021 · Terminated
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- Z-1259-2021 · Smisson-Cartledge Biomedical, LLC · posted Mar 26, 2021 · Terminated
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- Z-1260-2021 · Smisson-Cartledge Biomedical, LLC · posted Mar 26, 2021 · Terminated
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- Z-1190-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1191-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1192-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1193-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1194-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1195-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1196-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1197-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1198-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1199-2021 · Medtronic Perfusion Systems · posted Mar 17, 2021 · Terminated
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Z-1161-2021 · Acist Medical Systems · posted Mar 4, 2021 · Terminated
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is…
- Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. ↗Class IZ-1110-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1111-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1112-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1113-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1114-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- EMBLEM S-ICD Model A209 ↗Class IZ-0950-2021 · Boston Scientific Corporation · posted Feb 5, 2021 · Terminated
Electrical overstress may lead to device malfunction.
- Z-0951-2021 · Boston Scientific Corporation · posted Feb 5, 2021 · Terminated
Electrical overstress may lead to device malfunction.
- Z-0946-2021 · Heartware, Inc. · posted Feb 4, 2021 · Open, Classified
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall…
- Z-0925-2021 · Hill-Rom, Inc. · posted Jan 29, 2021 · Terminated
Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient
- Z-0879-2021 · Boston Scientific Corporation · posted Jan 19, 2021 · Terminated
There is potential for fractures which results in the inability to delivery therapy.
- Z-0848-2021 · Penumbra Inc. · posted Jan 18, 2021 · Terminated
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
- Z-0849-2021 · Penumbra Inc. · posted Jan 18, 2021 · Terminated
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
- Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KITClass IZ-0850-2021 · Penumbra Inc. · posted Jan 18, 2021 · Terminated
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
- Z-0851-2021 · Penumbra Inc. · posted Jan 18, 2021 · Terminated
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
- Z-0728-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Z-0729-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Z-0730-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Z-0734-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Z-0735-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Z-0736-2021 · Boston Scientific Corporation · posted Jan 9, 2021 · Terminated
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
About this data
- Unit: a recall record is one product in an FDA recall (one recall number, e.g. Z-1234-2021). 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 2021, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.