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
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
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 12, 2020	Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c...	Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)	Class I	Medtronic Vascular Galway DBA Medtronic Ireland
May 6, 2020	Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A...	A material weakness adjacent to the polymer fill channel may become compromised during pressuriza...	Class I	Endologix, Inc.
Apr 3, 2020	Heartware HVAD Pump Implant Kit, Product (REF) Number 1103	The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im...	Class I	Heartware, Inc.
Apr 3, 2020	Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125	The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im...	Class I	Heartware, Inc.
Apr 3, 2020	Heartware HVAD Pump Implant Kit, Product (REF) Number 1104	The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im...	Class I	Heartware, Inc.
Apr 3, 2020	Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP	The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im...	Class I	Heartware, Inc.
Apr 3, 2020	Heartware HVAD Pump Implant accessories, Product (REF) Number 1153	The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im...	Class I	Heartware, Inc.
Mar 24, 2020	CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ...	Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ...	Class I	Smiths Medical ASD Inc.
Mar 23, 2020	LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165...	There has been an increased trend in reports of catheters failing to deflate during use, which ma...	Class I	LeMaitre Vascular, Inc.
Mar 16, 2020	Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ...	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Feb 14, 2020	ev3 Pipeline Flex Embolization Device. For neurological endovascular use.	Embolization device delivery system may fracture at the distal section during device implantation...	Class I	Micro Therapeutics Inc, Dba Ev3 Neurovascular
Feb 14, 2020	ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For ...	Embolization device delivery system may fracture at the distal section during device implantation...	Class I	Micro Therapeutics Inc, Dba Ev3 Neurovascular
Feb 11, 2020	Imager II 5F Angiographic Catheters, 5 units per package.	Potential for tip detachment of Imager II 5F Angiographic Catheters	Class I	Boston Scientific Corporation
Feb 4, 2020	CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038...	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Feb 4, 2020	CareFusion Alaris PCA Module, Model 8120	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Feb 4, 2020	CareFusion Alaris Pump Module, Model 8100	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Feb 4, 2020	CareFusion Alaris Syringe Module, Model 8110	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Jan 29, 2020	NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular

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.