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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.