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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

3,029 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.

Clear
DateProductReasonClassFirm
Jan 14, 2016 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ... Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h... Class II Cardiac Science Corporation
Jan 14, 2016 Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is i... When a user performed radiography using the wireless FPD, a message window appeared on the monit... Class II Toshiba American Medical Systems Inc
Jan 14, 2016 BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... Class II Siemens Healthcare Diagnostics, Inc.
Jan 14, 2016 BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... Class II Siemens Healthcare Diagnostics, Inc.
Jan 13, 2016 iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800... Iris International noted loose or missing analyte pads found in several locations (strip vial, s... Class II Beckman Coulter Inc.
Jan 13, 2016 The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization... Water retention issues. Units with filters that remain wet after the sterilization may compromis... Class II PMBS, LLC
Jan 13, 2016 Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 104... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily... Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. Class II Resmed Corporation
Jan 13, 2016 Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer... The Firm has discovered a Software bug. Class II Olympus Scientific Solutions Americas
Jan 13, 2016 IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 13, 2016 IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE... The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class II Siemens Healthcare Diagnostics, Inc
Jan 12, 2016 Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... Class II Arrow International Inc
Jan 11, 2016 Product 72 consists of all product code: JDI and same usage: Item no: 805... 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 24 consists of all product under product code: HRS 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 44 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 Product 23 consists of all product code: JDI and same usage: Item no: 8011... 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 Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-const... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical... Blade exhibiting fracture during hip arthroscopy procedures Class II Smith & Nephew, Inc.
Jan 11, 2016 ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the... N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... Class II Horiba Instruments Inc
Jan 11, 2016 Product 21 consists of all product under product code: JDI 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 68 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 61 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 2 consists of all products product code LPH, and same usage: 8018022... 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 6 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 ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constr... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 55 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 Product 58 consists of all product under product code: HRS 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 NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 38 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 LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 33 consists of all product under product code: JDI 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 11 consists of all product under product code JDI , 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 57 consists of all product code: JDI and same usage: Item no: 7634... 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 39 consists of all product under product code: JDI 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 50 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 CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 9 consists of all product under HRS, and same usage: Item no: 4749... 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 32 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 Product 41 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 Product 26 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 PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Product 49 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 47 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 Product 40 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 71 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 13 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 Product 22 consists of all product under product code: JDI 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 Product 20 consists of all prod oct under poduct 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.

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.