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

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

Clear
DateProductReasonClassFirm
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental ... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product U... The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1... Class II Philips North America, LLC
Apr 10, 2020 Philips Zenition 50, System code 718096 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... Class II Philips North America, LLC
Apr 10, 2020 HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a componen... Damaged ESD bags used for storing components in Processor PCA Replacement Kits Class II Philips North America, LLC
Apr 10, 2020 Philips Zenition 70, System code 718133 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... Class II Philips North America, LLC
Apr 10, 2020 Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 045... Internal testing results showed endotoxin-related test result did not meet specifications for im... Class II Medtronic Inc.
Apr 9, 2020 WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Prod... One lot of INBONE Tibial Trays is missing the plasma coating. Class II Wright Medical Technology Inc
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P... The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. Class II CooperSurgical, Inc.
Apr 9, 2020 The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... A software issue that may affect the analyzer's result accuracy. Class II The Binding Site Group, Ltd.
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 There is a risk for a false mutation positive result in rare cases resulting from a fluorescence ... Class II Qiagen Sciences LLC
Apr 7, 2020 Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-2... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product... Ambulance Cots may not meet crash test standard BS EN 1789 Class II Stryker Medical Division of Stryker Corporation
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System used with the following Modules: High Vol... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 FlexLab Automation System used with the following Modules: High Volume Storag... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical... Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screw... Class II Innovasis, Inc
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 72001... If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. Class II Philips North America, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.

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.