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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
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.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 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, 16 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 15, 2016 Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used i... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the t... MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may hav... Class II Philips Electronics North America Corporation
Apr 6, 2016 Intubation Scope Intended to provide optical visualization of, therapeutic a... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude Medical Inc.
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Mar 17, 2016 Persona The Personalized Knee System Articular Surface Posterior Stabilized (... The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... Class II Zimmer Manufacturing B.V.
Mar 17, 2016 Persona The Personalized Knee System Articular Surface Posterior Stabilized (... The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... Class II Zimmer Manufacturing B.V.
Mar 16, 2016 da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & a... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Mar 16, 2016 da Vinci S Surgical System (IS4000) user manual English and OUS. Product U... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Mar 10, 2016 eCareCoordinator allows the customer to schedule patient tasks (i.e., take we... The adherence check generates a software error. Two issues occur as a result of the software err... Class II Philips Visicu
Mar 8, 2016 Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Dian... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock P... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Dr... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, 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.