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.

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DateProductReasonClassFirm
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.