Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Jul 12, 2018 Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... A size 22mm threaded peg was found in the package of a 10mm unit. Class II Zimmer Biomet, Inc.
Jun 21, 2018 Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 31, 2018 VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Pro... This lot of VentriClear failed endotoxin testing. Potential adverse events include immune respon... Class II Cook Inc.
May 25, 2018 Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... This voluntary recall is being conducted due to the curved tip introducer needle which is include... Class II Medtronic Neuromodulation
May 25, 2018 Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... This voluntary recall is being conducted due to the curved tip introducer needle which is include... Class II Medtronic Neuromodulation
May 24, 2018 Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 23, 2018 Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
May 23, 2018 Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
May 22, 2018 Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 18, 2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... The Internal packaging, the pouch and patient labels are improperly labeled. Class II OMNIlife science Inc.
May 18, 2018 Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY2... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, CO... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDM... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ... There is a potential for a disruption in one or more of the triple layer membranes of the ventric... Class I BERLIN HEART GMBH
May 9, 2018 Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Produ... There is a potential for a different set to be mixed within the lot, where the incorrect set does... Class II B. Braun Medical, Inc.
May 7, 2018 WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... Class I Biosense Webster, Inc.
May 3, 2018 HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (8612... The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may... Class II Philips Electronics North America Corporation
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 T... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO
Apr 5, 2018 Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu... Class I Abbott
Apr 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 ... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO
Apr 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 ... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO

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.