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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

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

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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
Jun 27, 2017 NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape... The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... Class II NOVADAQ TECHNOLOGIES INC.
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Us... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... Class II Hologic, Inc
Jun 26, 2017 Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Anal... Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... Class II Beckman Coulter Inc.
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... Class II Stryker Neurovascular
Jun 26, 2017 Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl... The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl... Class III Ameditech Inc
Jun 26, 2017 Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcath... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... Class II Stryker Neurovascular
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microca... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... Class II Stryker Neurovascular
Jun 26, 2017 Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the speci... Class II Implant Direct Sybron Manufacturing, LLC
Jun 26, 2017 Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva ... Burn Sheet has possibility of being shredded. Class II Certified Safety Mfg Inc
Jun 26, 2017 Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microca... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... Class II Stryker Neurovascular
Jun 26, 2017 Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematolog... Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... Class II Beckman Coulter Inc.
Jun 23, 2017 Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F... It has been determined that the reprocessing instructions may not provide sufficiently detailed i... Class II Xintec Corp
Jun 23, 2017 Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The product... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The product... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Truliant Tibial Trial Handle. To assist the surgeon in the implantation of... The Truliant Tibial Trial Handle's pin may disassociate from the main body. Class II Exactech, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case,... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,0... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,00... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case,... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, 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.