Browse Device Recalls

3,528 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,528 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 3,528 FDA device recalls — Class I.

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DateProductReasonClassFirm
Jun 30, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
Jun 30, 2020 Alaris System PC Unit Model 8015, 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 30, 2020 Alaris System PC Unit Model 8015. modular infusion pump and monitoring system If one or more screws or washers are loose or missing causing the battery not to be properly secu... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris Pump Module Model 8100, 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 30, 2020 Alaris Pump Module Model 8100 Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris EtCO2 Module Model 8300, 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 30, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
Jun 30, 2020 Alaris Auto ID Module Model 8600, 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 30, 2020 Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and mon... Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Spectrum IQ Infusion System with Dose IQ Safety Software Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
Jun 30, 2020 Alaris PCA Module Model 8120, 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 30, 2020 Alaris System PC Unit Model 8000, 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 30, 2020 Alaris System PC Unit Model 8000 modular infusion pump and monitoring system If one or more screws or washers are loose or missing causing the battery not to be properly secu... Class I CareFusion 303, Inc.
Jun 30, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Baxter is updating the device IFU for safety communication regarding cleaning practices. Class I Baxter Healthcare Corporation
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

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.