Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN00... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN00... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 10, 2022 | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... | Class I | Caire, Inc. |
| Oct 10, 2022 | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... | Class I | Caire, Inc. |
| Oct 10, 2022 | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... | Class I | Caire, Inc. |
| Oct 10, 2022 | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... | Class I | Caire, Inc. |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for ... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System,... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 8, 2022 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggering an alarm that is ... | Class I | Fresenius Kabi USA, LLC |
| Sep 6, 2022 | Philips Respironics Amara View Minimal Contact Full-Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Philips Respironics DreamWear Full Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Therapy Mask 3100 NC/SP | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Wisp and Wisp Youth Nasal Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | DreamWisp Nasal Mask with Over the Nose Cushion | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Aug 29, 2022 | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical ga... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circ... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only;... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS on... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 26, 2022 | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation suppo... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive v... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 9, 2022 | Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product C... | Firm noted an increase in customer reports of leaks. | Class I | Baxter Healthcare Corporation |
| Aug 9, 2022 | Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B | Products were distributed in the United States without FDA authorization or clearance. | Class I | DEWEI MEDICAL EQUIPMENT CO LTD |
| Aug 9, 2022 | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Ca... | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, o... | Class I | Jiangsu Well Biotech Co.,Ltd. |
| Jul 21, 2022 | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... | Class I | Cardiac Assist, Inc |
| Jul 20, 2022 | Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... | Ventilators may generate a combination of alarms which may result in loss of communication, techn... | Class I | Getinge Usa Sales Inc |
| Jul 12, 2022 | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1 | Distributed VTM outside of VTM Guidance and without clearance. | Class I | Haimen Shengbang Laboratory Equipment Co. Ltd. |
| Jul 12, 2022 | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Act... | Distributed VTM outside of VTM Guidance and without clearance. | Class I | Haimen Shengbang Laboratory Equipment Co. Ltd. |
| Jul 12, 2022 | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made | Distributed VTM outside of VTM Guidance and without clearance. | Class I | Haimen Shengbang Laboratory Equipment Co. Ltd. |
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.