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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 19, 2017 Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Tow... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Apr 19, 2017 ARIES System and ARIES M1 System The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen i... Class II Luminex Corporation
Apr 19, 2017 High Frequency Resection Electrodes, endoscope, ac-powered and accessories T... Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. Class II Olympus Corporation of the Americas
Apr 19, 2017 White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Inte... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Apr 19, 2017 Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps ar... There is a material mislabeling of the AFN End Cap. Class II Ortho Solutions Inc
Apr 18, 2017 ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator... ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR... Class II ELITech Clinical Systems SAS
Apr 18, 2017 ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent micr... Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube t... Class II Abbott Laboratories
Apr 17, 2017 Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number:... Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. Class II Madison Polymeric Engineering
Apr 17, 2017 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... nail not properly engaging with the targeting jig due to certain undersized specification Class II Zimmer Biomet, Inc.
Apr 17, 2017 SonarMed AirWave Monitor, Model Number M0001 Potential for the presence of two error codes which would make the monitor inoperable. Class II SonarMed Inc
Apr 17, 2017 Nonabsorbable suture anchor system intended to reattach soft tissue to bone i... Manufactured with the incorrect anchor outer body Class II ConMed Corporation
Apr 14, 2017 Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in ... Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine t... Class II Del Mar Reynolds Medical, Ltd.
Apr 14, 2017 CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusi... Class II Cardiovascular Systems Inc
Apr 13, 2017 Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-... There is a potential for the gel packets to have leaks in the packet seal. Class II Parker Laboratories, Inc.
Apr 13, 2017 ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative techn... QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... Class II BioMerieux SA
Apr 13, 2017 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used t... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ... Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i... Class II Medtronic Sofamor Danek USA Inc
Apr 13, 2017 ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative tec... QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... Class II BioMerieux SA
Apr 13, 2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... Class II Zimmer Biomet, Inc.
Apr 13, 2017 CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an elec... Software bug which allows parameters to be changed unintentionally during use. Class II CardioTek BV
Apr 13, 2017 Access BR Monitor, Part No. 387620 Following biases observed in the results of the French National Quality Controls, Beckman Coulter... Class II Beckman Coulter Inc.
Apr 13, 2017 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to el... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 13, 2017 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronicall... Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... Class II Pentax of America Inc
Apr 12, 2017 LASER CDS Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... Class II Medline Industries, Inc.
Apr 12, 2017 Laparoscopy CDS One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled st... Class II Medline Industries, Inc.
Apr 12, 2017 Cardiac Insulation Pad, OPEN HEART CDS Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation ... Class II Medline Industries, Inc.
Apr 12, 2017 Savaria SL-1000 Stairlift The electrical controller, combined with motor, causes feedback, damaging a component on the cont... Class II Savaria Concord Lifts, Inc.
Apr 12, 2017 Bone Dowell Harvest Tubes mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously subst... Class II Zimmer Biomet, Inc.
Apr 12, 2017 The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for ... Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product def... Class II Savaria Concord Lifts, Inc.
Apr 12, 2017 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The produc... The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cob... Class II XTANT MEDICAL INC
Apr 12, 2017 Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu... An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Apr 12, 2017 PICC Tray, STERILE, 12 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 12, 2017 SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & ... Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION ... Class II Datascope Corporation
Apr 12, 2017 AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a... An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Per... Class II Siemens Medical Solutions USA, Inc
Apr 12, 2017 Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi... The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the ... Class II Vascular Solutions, Inc.
Apr 12, 2017 Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 12, 2017 Omega Incline Platform Lift Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift ... Class II Savaria Concord Lifts, Inc.
Apr 11, 2017 EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... Patient results determined using this calibrator lot might deviate up to 20%. Controls might not ... Class II Medica Corporation
Apr 11, 2017 PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 Part of the number on the tray lid differ from the part number on the base. Class II Biomet Microfixation, LLC
Apr 11, 2017 INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF

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.