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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

2,522 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.

Clear
DateProductReasonClassFirm
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.
Feb 25, 2016 31" (79 cm) Appx. 3.4 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. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... 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. 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. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Jan 29, 2016 Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi... Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur... Class II Biomet, Inc.
Jan 11, 2016 NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 7, 2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... Heartware Ventricular Assist System Battery Cell experiencing premature depletion. Class I Heartware, Inc.
Dec 23, 2015 Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... The sterile battery may contain particulates within the sterile package. Class II Pro-Dex Inc
Dec 23, 2015 Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... The sterile battery may contain particulates within the sterile package. Class II Pro-Dex Inc
Dec 14, 2015 Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; ... Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assem... Class II Mizuho OSI
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Dec 2, 2015 Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for di... The hardware that holds the VESA plate and the display interface / monitor to the bracket may fai... Class II Skytron, Div. The KMW Group, Inc
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Label reading in part as: "NexGen System, Complete Knee Solution; Reference N... Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th... Class II Zimmer Manufacturing B.V.

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.