Browse Device Recalls

47 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 47 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 47 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2024 Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray w... Reports have been received regarding open seals on the packaging. Class II ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL 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.
Aug 10, 2023 Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pr... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS ... This recall has been initiated due to reports that the product code and product name were incorre... Class II ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC p... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; cathe... This recall has been initiated due to reports that the product code and product name were incorre... Class II ARROW INTERNATIONAL Inc.
May 19, 2023 ARROW Endurance Extended Dwell Peripheral Catheter System Potential for catheter separation or leakage Class I ARROW INTERNATIONAL Inc.
Oct 27, 2022 Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheter... There is the potential for inadequate connection between the top and bottom housings of the Micro... Class I ARROW INTERNATIONAL Inc.
Oct 27, 2022 Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)... There is the potential for inadequate connection between the top and bottom housings of the Micro... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP... 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 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, 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 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 AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... 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 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 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 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 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 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, AC3 IABP NA/AJLA, REF IAP-0601(IPN... 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 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 AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... 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 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 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, AC3 IABP NA/EMEA, REF IAP-0600 (IP... 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, AEROAUTOCAT2, REF IAP-0435 (IPN000... 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, AEROAUTOCAT 2 WAVE, REF IAP-0535 (... 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, AEROAUTOCAT2 WAVE REFURBISHED, REF... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Sep 14, 2022 ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ... Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe... Class II ARROW INTERNATIONAL Inc.
May 5, 2022 Arrow Three-Lumen CVC Gravity flow rates on the affected product lidstock are incorrect. Class II ARROW INTERNATIONAL 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.