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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
Aug 10, 2016 TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Adm... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Port... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Rigid Suction Canister 3000 CC and 2000 CC. Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure dur... Class II Medline Industries Inc
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 m... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sam... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Produc... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservo... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Sque... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Nee... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and N... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reser... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 9, 2016 ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system u... Possible injury due to movement of the arm, calibration loss and communication loss. Class II Swissray Medical
Aug 9, 2016 Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve ... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter The recalling firm identified ten devices which were distributed and could potentially be non-com... Class II EKOS Corporation
Aug 9, 2016 Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling in... Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exi... Class II Hill-Rom, Inc.
Aug 9, 2016 Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and O... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can b... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Aug 9, 2016 MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter... The multi-sample needle retractable sheath may not fully retract over the needle during the chang... Class II Global Healthcare Inc
Aug 9, 2016 Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and... Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F... Class II Zimmer Biomet, Inc.
Aug 9, 2016 ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/S... Communication provided to emphasize that the PSA values should be interpreted in accordance with ... Class II Siemens Healthcare Diagnostics, Inc
Aug 8, 2016 Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syr... A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to ... Class II CareFusion 303, Inc.
Aug 8, 2016 BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm... Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection S... Class II Becton Dickinson & Company
Aug 8, 2016 UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 6... There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 wher... Class II Beckman Coulter Inc.
Aug 8, 2016 Vanguard 360 Revision Knee System Knee prostheses The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolt... Class II Zimmer Biomet, Inc.
Aug 8, 2016 Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Produc... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Aug 8, 2016 Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrat... Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from... Class II Siemens Healthcare Diagnostics, Inc
Aug 8, 2016 Arterial Line Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Aug 8, 2016 Radial Artery Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Aug 8, 2016 BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in... BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push... Class II Becton Dickinson & Company
Aug 8, 2016 SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis ... Class II Nidek Inc
Aug 8, 2016 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. Product was incorrectly packaged. Class II Biomet 3i, LLC
Aug 7, 2016 Proteus 235 The PTS is a medical device designed to produce and deliver ... IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance te... Class II Ion Beam Applications S.A.
Aug 5, 2016 Syngo.via picture archiving and communication system Syngo via is a softwa... Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... Class II Siemens Medical Solutions USA, Inc
Aug 5, 2016 Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile... Polypropylene Surgical Sutures are recalled because the seals may become open during distribution... Class II Riverpoint Medical, 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.