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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Jan 11, 2016 Product 66 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 70 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 63 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 53 consists of all product under: product code: JWH and same usage... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 60 consists of all product under product code: HSB and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 30 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay ... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 69 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 46 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Jan 11, 2016 NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotib... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model nu... When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segm... Class II Varian Medical Systems, Inc.
Jan 11, 2016 ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantit... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 16 consists of all product under poduct code: KWY and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 4 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 43 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 42 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 56 consists of all product under product code: HWC and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads N... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 15 consists of all product code JDI , and same usage: Item no: 80... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 3 consists of all products under product code JDI, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 8 consists of all products under product code HWC, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 7 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 27 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 37 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 64 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 1 consists of all product under , product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 54 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 67 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for t... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 35 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 19 consists of all product code: JDI and same usage: Item no: 7653... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 62 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 14 consists of all product under product code HSB , and same usage:... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 65 consists of all product under product code: KTT and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 10consists of all product under product code HWC, and same usage: It... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 59 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay fo... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 34 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 45 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 17 consists of all product under product code: LPH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixa... Potential for a component contained in the Implant System to be non-sterile. Class II Arthrex, Inc.
Jan 11, 2016 Product 36 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Leica Microsystems (Schweiz) Ag. The common name of the device is surgical mi... An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W i... Class II Leica Microsystems, Inc.
Jan 11, 2016 NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 51 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.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.