Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
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
Apr 2, 2018 AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog N... Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... Class II AESDEX
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 22, 2018 Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intende... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 22, 2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intend... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Di... Class II Invivo Corporation
Mar 2, 2018 BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... Class II Beckman Coulter Inc.
Mar 1, 2018 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotatin... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Cl... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Ch... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cle... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotati... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.... Class II ICU Medical de Mexico, S.A. de C.V.

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.