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.

Clear
DateProductReasonClassFirm
Jun 30, 2020 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 26, 2020 Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, ... Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... Class I Smiths Medical ASD Inc.
Jun 26, 2020 Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... Class I Smiths Medical ASD Inc.
Jun 16, 2020 BodyGuard Microset, REF: A120-161XPS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset With Female Luer, REF: A120-160XPSN Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-160X2YB Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard BodySet, REF: A120-160SAS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-160XSFK Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Sets, REF: A120-161C Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: ... Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard set with Female Luer, REF: A120-003XSN Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Filter, REF: A120-160XSFE Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-161XPSV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-161XYBS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A100-163XSL Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 Standard BodySet with Needleless Connectors, REF: A120-125XS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Filter, REF: A100-164XESF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A100-163XE90S Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-003XS2YV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: ... Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-112XSFK Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-160XYSF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A100-163XESV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Filter, REF: A100-163XESF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Set, REF: A120-160C Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Set, REF: A120-160CRV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-160XPS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-160GCFA Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-161XYB Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A100-163XSFL Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Set, REF: A120-161CYF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Sets, REF: A120-160C2YRV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A120-125XSE Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset, REF: A100-163XES Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 CMExpress Microbore Sets, REF: A120-160CYFRV Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 5, 2020 GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the Gli... When video laryngoscopy system users apply, twisting motions while connecting the blade in the HD... Class I Verathon, 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 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 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 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 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 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 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 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 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

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.