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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
May 16, 2014 Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate ... Several complaints were received for the metal support tube missing from the cholangiogram catheter. Class II Teleflex Medical
May 16, 2014 GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in ... Class II Nidek Inc
May 16, 2014 Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Numbe... Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actua... Class II Alcon Research, Ltd.
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Cur... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetr... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use o... An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address ... Class II Siemens Medical Solutions USA, Inc
May 15, 2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simpl... Class II Focus Diagnostics Inc
May 15, 2014 DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT T... Surface finish is different than specified. The implant has 30 grit blast on the exterior of the... Class II Biomet, Inc.
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming... All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the pack... Class II Synthes, Inc.
May 15, 2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrumen... The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Class II Ebi, Llc
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetri... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T pro... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Cu... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial... The original mean assigned to the control too high, upon reassignment with additional data the ne... Class III Medtest Holdings, Inc.
May 15, 2014 Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T prod... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 15, 2014 Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical... The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014)... Class II Bacterin International, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Sys... Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were pote... Class II Beckman Coulter Inc.
May 14, 2014 MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Pan... Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion... Class II Beckman Coulter, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 13, 2014 Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, ... Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t... Class II Hologic, Inc.
May 13, 2014 The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... Class II Stryker Instruments Div. of Stryker Corporation
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 Hologic M-IV Mammography System; Model M4--00001. Intended to produce radi... Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t... Class II Hologic, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe... Class III DeVilbiss Healthcare LLC
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 The NAV3i Platform Power Box supplies the electrical components with power (e... The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... Class II Stryker Instruments Div. of Stryker Corporation
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonograph... Sterility of the device may be compromised due to unsealed pouch Class II CooperSurgical, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate... Unit was mislabeled with a factory label showing 32 KW output power. Class III AGFA Healthcare Corp.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, 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.