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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
Apr 13, 2015 Elastic Knee Support. A limb orthosis (brace) is a device intended for med... The product does not bear the caution label regarding latex content. Potential for Allergic skin... Class II United Surgical Associates
Apr 13, 2015 ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bo... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 Elastic Ankle Support. A limb orthosis (brace) is a device intended for me... The product does not bear the caution label regarding latex content. Potential for Allergic skin... Class II United Surgical Associates
Apr 13, 2015 SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medi... Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... Class II Siemens Medical Solutions USA, Inc
Apr 13, 2015 ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cu... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) ... The product does not bear the caution label regarding latex content. Potential for Allergic skin... Class II United Surgical Associates
Apr 13, 2015 ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 10, 2015 Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-4... Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II ... Class II Medtronic Neuromodulation
Apr 10, 2015 Female Driver, Part number FDr101, instrument used for the insertion of the F... The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0... Class II Pega Medical Inc.
Apr 10, 2015 EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EP... When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weig... Class II Philips Ultrasound, Inc.
Apr 10, 2015 EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EP... When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weig... Class II Philips Ultrasound, Inc.
Apr 10, 2015 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine S... During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been bot... Class II Alphatec Spine, Inc.
Apr 9, 2015 Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... Class II Coloplast Manufacturing US, LLC
Apr 9, 2015 IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement... IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parame... Class II Siemens Healthcare Diagnostics, Inc.
Apr 9, 2015 TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractur... TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the ... Class II Synthes, Inc.
Apr 9, 2015 Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... Some rods may not meet the appropriate traceability requirements including the lot number. Some ... Class III Spinal Elements, Inc
Apr 9, 2015 BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm... The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having s... Class II Bard Peripheral Vascular Inc
Apr 9, 2015 Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring e... On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the ... Class II BTE Technologies, Inc.
Apr 9, 2015 Merge RadSuite software. Radiological image processing system. When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... Class II Merge Healthcare, Inc.
Apr 8, 2015 ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Editi... Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possib... Class II Baxter Corporation Englewood
Apr 7, 2015 HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter... HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as con... Class II Catheter Research, Inc
Apr 7, 2015 Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine System... The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. Class II X Spine Systems Inc
Apr 6, 2015 VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-... Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... Class II Ortho-Clinical Diagnostics
Apr 6, 2015 Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfa... GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental becaus... Class II GA Industries
Apr 6, 2015 VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-... Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... Class II Ortho-Clinical Diagnostics
Apr 6, 2015 Assay Data Disk (ADD), All DRV versions that support product within expiry da... Software anomaly regarding urine samples that require acidified pretreatment. The software has a... Class II Ortho-Clinical Diagnostics
Apr 6, 2015 VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre... Software anomaly regarding urine samples that require acidified pretreatment. The software has a... Class II Ortho-Clinical Diagnostics
Apr 3, 2015 CareFusion AVEA ventilator, all models. Product Usage: A continuous venti... A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occl... Class I Carefusion 211 Inc dba Carefusion
Apr 3, 2015 Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determin... Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in u... Class II Medtest Holdings, Inc.
Apr 2, 2015 Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncol... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Int... The affected lot is being recalled because it was packaged without the locking screw. The lockin... Class II Zimmer, Inc.
Apr 2, 2015 Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Cli... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Di... Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been inst... Class II Siemens Healthcare Diagnostics, Inc.
Apr 2, 2015 MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma dete... The probability and histogram data within the Melafind's device displayed user interface lacks ap... Class II MELA Sciences, Inc.
Apr 2, 2015 Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Pat... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialy... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ... In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas l... Class I Maquet Cardiovascular Us Sales, Llc
Apr 2, 2015 Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Onco... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco XL Convalescent Recliner - with Steel Casters Long term patient reclin... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC

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.