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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
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 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Jul 20, 2016 BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... Class II Cardinal Health
Jul 15, 2016 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 1, 2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... Class I Carefusion 2200 Inc
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 22, 2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... Risk associated with operating the device in skin temperature mode with temperature sensors attac... Class II Draeger Medical, Inc.
Jun 14, 2016 T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged i... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 5... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches p... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. P... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, wit... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Fre... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 po... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
Jun 6, 2016 SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... Class II Siemens Medical Solutions USA, Inc
Jun 1, 2016 PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoeni... BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol... Class III Becton Dickinson & Co.
Jun 1, 2016 PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ... BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following... Class III Becton Dickinson & Co.
May 23, 2016 OT1000 Series Orthopedic Surgical Tables STERIS has identified that the pivot pin assembly located on the table top may become loose preve... Class II Steris Corporation
May 17, 2016 Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder ... In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from... Class II Zimmer Gmbh
May 9, 2016 SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
May 9, 2016 VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784,... Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products... Class III ORTHO-CLINICAL DIAGNOSTICS
May 9, 2016 SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
May 6, 2016 Ariol is an automated scanning microscope and image analysis system. It is in... An issue during the manufacturing process caused systems to have an improperly activated Windows ... Class III Leica Biosystems Richmond Inc.
May 4, 2016 Periarticular plating system, cancellous bone screw, partially threaded, hex ... A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... Class II Zimmer Manufacturing B.V.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. ... Class II Acumedia Manufacturers, 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.