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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

3,313 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
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Len... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Ite... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 ... Listeria monocytogenes contamination of non-sterile plated media Class II Becton Dickinson & Co.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item ... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/ED... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
May 22, 2017 Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, It... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 19, 2017 GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX ... It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Revolution EVO X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT660, CT680 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Mul... Software defect Class II Neusoft Medical Systems Co., Ltd.
May 19, 2017 GE Healthcare Discovery NM/CT 670 CZT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Lightspeed RT16 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare LightSpeed VCT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 0084527500... An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... Class II Fisher Diagnostics
May 19, 2017 BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot... Class II CryoLife, Inc.
May 19, 2017 GE Healthcare Discovery IQ X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H... One lot of product does not include a screw for attachment to the tibial base plate. Class II Medacta Usa Inc
May 19, 2017 GE Healthcare Optima CT540 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml DR X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determ... An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... Class II Fisher Diagnostics
May 19, 2017 GE Healthcare Discovery NM/CT 570c X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: Neu... Software defect Class II Neusoft Medical Systems Co., Ltd.
May 19, 2017 GE Healthcare BrightSpeed X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare lnnova IGS 540 ACT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT520 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... Class II Biosense Webster, Inc.
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... Class II Biosense Webster, Inc.
May 17, 2017 QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dres... Packaging breach may compromise sterility Class II Z-Medica, LLC
May 17, 2017 KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. The directional arrow at the proximal end of the instrument may not correctly align with the cut... Class II Medtronic Sofamor Danek USA Inc
May 16, 2017 Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 109... Software error. In Sensis Vibe systems with software version VD10B, a software error can result ... Class II Siemens Medical Solutions USA, Inc
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactec... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 16, 2017 VITEK 2 Gram Negative test kits containing colistin (cs01n) The investigation demonstrated a high rate of very major errors (resistant isolates calling susce... Class II Biomerieux Inc
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exacte... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 15, 2017 CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product U... One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, inco... Class II Smiths Medical ASD Inc.
May 15, 2017 FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... Class II Boston Scientific Corporation
May 15, 2017 VIDAS Testosterone, Ref 30418 Complaints were received from customers observing falsely overestimate results or external qualit... Class II bioMerieux, Inc.
May 15, 2017 Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: ... The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 w... Class II Beckman Coulter Inc
May 15, 2017 Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... Potential for electric shock in the case of a failure to install the grommets, supplied with the ... Class II Perkinelmer Life Sciences, Inc.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 ... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 P... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.

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.