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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

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Browse Device Recalls

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

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DateProductReasonClassFirm
Jan 27, 2022 HeartWare Ventricular Assist Device (HVAD) System Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B... Class II Heartware, Inc.
Jan 27, 2022 LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... Class II Integrity Implants Inc.
Jan 27, 2022 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul... Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... Class II Integrity Implants Inc.
Dec 22, 2021 ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 NIM TRIVANTAGE EMG Endotracheal Tube There is potential for multiple issues due to a manufacturing nonconformity. Class II Medtronic Xomed, Inc.
Dec 22, 2021 CovClear COVID-19 Rapid Antigen Test, ATG 900-031 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 Destino Twist 14F (also branded as Guidestar 14F) There is potential for separation between the threaded hub and threaded cap at the proximal end o... Class II Oscor Inc.
Dec 15, 2021 Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... Class II Medtronic Xomed, Inc.
Oct 1, 2021 SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Oct 1, 2021 SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Oct 1, 2021 SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Oct 1, 2021 SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is in... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Oct 1, 2021 SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Oct 1, 2021 SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic Sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Com... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Ti... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Component... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a.... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylen... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 12, 2021 EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiP... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I AMTEC SALES Inc
Aug 6, 2021 Medtronic HVAD Pump Implant Kits There is more force required to slide the driveline cover (boot cover) away from the connector af... Class II Heartware, Inc.
Jul 27, 2021 CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-Co... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qual... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential D... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differen... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,... Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 19, 2021 Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X The balloon protective sheath may potentially be contaminated with a foreign material left over f... Class II Cordis Corporation
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.

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.