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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

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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

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

Clear
DateProductReasonClassFirm
Dec 5, 2016 EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... Unique Device Identifier (UDI) is missing from outer kit box label. Class III PerkinElmer Health Sciences, Inc.
Dec 2, 2016 RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical... Lack of sterility assurance Class II Biom'up
Dec 2, 2016 McKesson Radiology 12.2 - Picture Archive Communication System (PACS) Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McK... Class II Mckesson Medical Imaging
Nov 29, 2016 Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 ... Certain lots are showing an atypical decrease in optical density (OD) over time, which may result... Class II Sekisui Diagnostics P.E.I. Inc.
Nov 18, 2016 ddR Formula B X-ray System, Model ddR Formula B X-ray system used for ima... Potential for bucky (the part that holds the grid and is moveable to position the patient) moving... Class II Swissray Medical
Nov 9, 2016 RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System... Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation ... Class II RAYSEARCH LABORATORIES AB
Oct 28, 2016 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usag... IBA is initiating this recall to address an issue identified with AdaPTinsight software and to re... Class II Ion Beam Applications S.A.
Oct 25, 2016 SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Ca... Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to th... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 11, 2016 Radiation Therapy Treatment Planning System Product Usage: RayStation is... An error may occur with the display of dose computed on images other than the planning CT (auxili... Class II RAYSEARCH LABORATORIES AB
Oct 5, 2016 VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 107587500062... The device defect is a positive bias of up to 20% relative to the currently marketed Roche device... Class II ORTHO-CLINICAL DIAGNOSTICS
Oct 4, 2016 FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed ... Inpeco received several notifications from the field about burnt schuko sockets. The customers re... Class II Inpeco S.A.
Sep 24, 2016 BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provid... Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential ... Class II Surgical Specialties Mexico S DE RL DE CV
Sep 16, 2016 12C IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... Class II Ion Beam Applications S.A.
Sep 16, 2016 Proteus ONE and Proteus Plus IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or ... Class II Ion Beam Applications S.A.
Sep 15, 2016 SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Modu... Class II SenTec AG
Sep 7, 2016 IgE Calibrator Series According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now ... Class II Randox Laboratories Ltd.
Sep 1, 2016 Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifuncti... There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillat... Class I Leonhard Lang Medizintechnik GmbH
Sep 1, 2016 RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radi... RaySearch became aware of the problem as it was discovered in cooperation with a customer experim... Class II RAYSEARCH LABORATORIES AB
Aug 31, 2016 NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P0... The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... Class II Neusoft Medical Systems Co., Ltd.
Aug 31, 2016 NeuViz 64 Multi-slice CT Scanner Systems The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... Class II Neusoft Medical Systems Co., Ltd.
Aug 18, 2016 NIO-A / NIO-P is an instant IO access device comprises housing with spring lo... WaisMed received a report in which during the operation of the NIO-A, the needle was not released... Class II Waismed Ltd
Aug 16, 2016 Pathfast D-Dimer, Reference number: PF1051-KUS Two complaints were received about decrease in sensitivity (control value and/or calibration valu... Class II Lsi Medience Corporation
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 2, 2016 Randox Lipase (Colorimetric) Product Usage: A lipase test system is a dev... According to the firm carry over was observed when the Lipase test is run directly before or afte... Class II Randox Laboratories Ltd.
Jul 28, 2016 VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product... A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than ex... Class III ORTHO-CLINICAL DIAGNOSTICS
Jul 21, 2016 SMR allen wrench 5 mm, product code 9013.50.210 Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of th... Class II Limacorporate S.p.A
Jul 12, 2016 Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: Th... Software malfunction; The action being taken due to the device becoming inoperable due to softwa... Class III ELITech Group B.V.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered Bone drill (V... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered dental handpi... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 1, 2016 RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.... An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation... Class II RAYSEARCH LABORATORIES AB
Jun 30, 2016 Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint meta... Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging o... Class II Zimmer Gmbh
Jun 24, 2016 Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC... Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. Class II Moller Vital
Jun 23, 2016 Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product... Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increase... Class II Philips Medical Systems Nederlands
Jun 20, 2016 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control ... Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because o... Class II Medtronic Navigation
Jun 15, 2016 EVA Floor Lifts, Model Numbers: 400, 450, 600 After feedback from customers and internal suspicion, Handicare has become aware that abnormal us... Class II Handicare AB
Jun 6, 2016 Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) The device is being recalled because dynamic loading forces from larger patients can fracture the... Class II Esaote S.p.A.
May 31, 2016 METS SMILES Total Knee Replacement The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the inten... Class II Stanmore Implants Worldwide Ltd.
May 30, 2016 Radiation Therapy Treatment Planning System, Model 5.0 For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in ... Class II RAYSEARCH LABORATORIES AB
May 18, 2016 Proteus 235 and Proteus ONE proton therapy systems Recall is being initiated to address on-site software installations not being performed consisten... Class II Ion Beam Applications S.A.
May 17, 2016 Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing N... Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the I... Class II CSL Behring GmbH
May 10, 2016 Double Pump RF Patient Cassette; Product Number: 72204055. Intended to pro... Sterility of device may be compromised due to sterile package breakage. Class II Medical Vision Ab
May 6, 2016 Best Theratronics cabinet x-ray systems intended for use in the irradiation o... It was discovered that both the new device and the predicate device failed to comply with perform... Class II BEST THERATRONICS LTD.
May 5, 2016 Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser ... Failure to provide the required instructions specifying a procedure and schedule for calibration ... Class II Ellipse A/S
May 5, 2016 Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Produ... Failure to provide the required instructions specifying a procedure and schedule for calibration ... Class II Ellipse A/S
May 4, 2016 ExacTrac Vero is a Patient Positioning System for Radiation therapy. Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Ve... Class II Brainlab AG
Apr 15, 2016 VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class III Biomerieux France Chemin De L'Or
Apr 14, 2016 Magnesium on RX Imola analyser IVD According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run... Class II Randox Laboratories, Limited
Apr 12, 2016 Distal Femoral Replacement (patient specific, custom made orthopedic implant ... Incorrect component used to manufacture distal femoral replacement. Class II Stanmore Implants Worldwide Ltd.
Apr 8, 2016 SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SM... Complaints of intra-operative breakage of the glenosphere impactors/extractors. Class II Limacorporate S.p.A

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.