Browse Device Recalls

3,435 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,435 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 3,435 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Aug 4, 2020	BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assemb...	Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress p...	Class I	CareFusion 303, Inc.
Aug 4, 2020	Alaris System PC Unit Model 8015	The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre...	Class I	CareFusion 303, Inc.
Aug 4, 2020	BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari...	The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in...	Class I	CareFusion 303, Inc.
Aug 4, 2020	PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ...	The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre...	Class I	CareFusion 303, Inc.
Jul 31, 2020	PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, ...	MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra...	Class I	MicroPort Orthopedics Inc.
Jul 31, 2020	PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01...	MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra...	Class I	MicroPort Orthopedics 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 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

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.