Browse Device Recalls

478 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 478 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 478 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. int... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-0715... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. intr... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Co... Marketed without a 510K Class II Arrow International Inc
Mar 8, 2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the b... Class II Arrow International Inc
Jan 6, 2021 Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the... The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. Th... Class II Arrow International Inc
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code ... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code ... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IA... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 8, 2020 Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Produc... Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-0552... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... 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.