Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2024 | Mojo Full Face with Headgear, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | Mojo 2 Full Face Non Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Mojo 2 Full Face AAV Non Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | iQ 2 Nasal Vented Mask | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Phantom 2 Nasal Vented Mask | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | Mojo 2 Full Face Vented Mask, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Mar 1, 2024 | Mojo Non Vented Full Face Mask with Headgear, All Sizes | Update to contraindications and warning language due to CPAP masks containing magnets. | Class I | SleepNet Corporation |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... | Class I | Smiths Medical ASD Inc. |
| Feb 26, 2024 | Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... | Complaints have been received that the device inflation tube detached and/or tore from the main t... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2024 | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 21, 2024 | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 20, 2024 | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... | Class I | Boston Scientific Corporation |
| Feb 19, 2024 | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 13, 2024 | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver ... | Class I | DeRoyal Industries Inc |
| Feb 12, 2024 | ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Nu... | Teleflex is initiating this voluntary recall for the above-mentioned products due to reports rece... | Class I | ARROW INTERNATIONAL Inc. |
| Feb 12, 2024 | Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 | Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... | Class I | Boston Scientific Corporation |
| Feb 7, 2024 | smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... | Class I | Smiths Medical ASD Inc. |
| Feb 7, 2024 | smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... | Class I | Smiths Medical ASD Inc. |
| Feb 2, 2024 | CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS909... | Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractur... | Class I | Medos International Sarl |
| Jan 23, 2024 | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Adapter 4 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 18 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Catheter Ext. 6 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 9, 2024 | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-010... | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Det... | Class I | Ventec Life Systems, Inc. |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 29, 2023 | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.