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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by... The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... Class II DeRoyal Industries Inc
Jun 4, 2014 DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: ... The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... Class II DeRoyal Industries Inc
Jun 4, 2014 ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... Software corrections reactivating the cooperative endoscopy mode. Class II Zimmer Biomet, Inc.
Jun 4, 2014 Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a compone... In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator con... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for us... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
Jun 4, 2014 GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolut... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
Jun 4, 2014 PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Sin... Possible leak from the filter allowing a small of amount of air to be released from the junction ... Class II Pall Corporation
Jun 3, 2014 ACL TOP CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 300 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. R... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30... There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on ... Class II Siemens Medical Solutions USA, Inc.
Jun 3, 2014 CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201... Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may un... Class II Nihon Kohden America Inc
Jun 3, 2014 eye-pak 7407 Tray Support Cover REF 8065740745 The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot... Class II Alcon Research, Ltd.
Jun 3, 2014 RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manua... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 ACL TOP 700 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 700 LAS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator Syst... Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventila... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 3, 2014 ACL TOP 700, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP (Base), automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sl... The product can be difficult to remove from the Distal Stem both out of the package and after pro... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 ACL TOP 500 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 2, 2014 RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed o... Class II Ability Dynamics LLC
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWri... Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Man... Class II Intuitive Surgical, Inc.
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centa... Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles Class II Siemens Healthcare Diagnostics, Inc
Jun 2, 2014 MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrume... Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becomin... Class II Siemens Healthcare Diagnostics, Inc.
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o... Class III Alere San Diego, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and... A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Tec... Class II Carestream Health Inc.
May 30, 2014 ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), ... The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker ... Class II Siemens Healthcare Diagnostics, Inc
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for monopolar electrode... Class II Instrumed International, Inc.
May 29, 2014 MOSAIQ MOSAIQ is an oncology information system used to manage workflows f... MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other t... Class II Elekta, Inc.
May 29, 2014 Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found... Class II Synthes, Inc.
May 29, 2014 iGUIDE System Product Usage: The intended use of the device is the contro... A bug in the software prevents the iGUIDE software from logging off. Class II Elekta, Inc.
May 29, 2014 Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3... Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-... Class II Kerr Corporation
May 29, 2014 Horizon Medical Imaging Horizon Medical Imaging is a medical image and inf... Firm received a complaint that an unreported study performed that day could not be opened from th... Class II Mckesson Medical Immaging

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.