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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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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.

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DateProductReasonClassFirm
Feb 28, 2018 Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)... A potential commingle that could result in the product in the package not matching the product o... Class II Zimmer GmbH
Feb 28, 2018 Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)... A potential commingle that could result in the product in the package not matching the product o... Class II Zimmer GmbH
Feb 27, 2018 AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... Class II Radiometer Medical ApS
Feb 23, 2018 Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is m... There have been patient reports of abdominal hernia recurrence following hernia repair. The recal... Class II Sofradim Production
Feb 13, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Au... Module may freeze without generating user warning. There is a potential risk in delay of sample p... Class II Inpeco S.A.
Feb 5, 2018 ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualita... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 5, 2018 ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative scr... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 5, 2018 ZYMUTEST HIA MonoStria qualitative screening assay intended for the global de... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 2, 2018 Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... This recall has been identified due to the batch being mislabeled, with the packaged component's... Class II Signature Orthopedics Pty Limited
Jan 30, 2018 TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... The firm received complaints regarding the incompatibility and dimensional interference between ... Class II Orthofix Srl
Jan 26, 2018 Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam f... When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the t... Class II Ion Beam Applications S.A.
Jan 4, 2018 Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended... The low and high controls for the product are returning results above the assigned values. Class II The Binding Site Group, Ltd.
Jan 3, 2018 MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... Class II ESAOTE S.P.A.
Jan 3, 2018 MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, ... The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... Class II ESAOTE S.P.A.
Dec 28, 2017 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant ace... Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is i... Class II IMPLANTCAST GMBH
Dec 14, 2017 ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar... Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from ... Class II Abbott Gmbh & Co. KG
Dec 8, 2017 MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Acc... Due to a system controller software anomaly, the patient positioning deviation correction may not... Class II Hitachi Ltd., Medical System Operations Group
Dec 4, 2017 CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following pr... A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, a... Class II Cellavision AB
Dec 2, 2017 Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software versi... Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusio... Class II Fresenius Vial Sa
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF ... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 27, 2017 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF T... Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... Class II SPINEART SA
Nov 24, 2017 U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Nov 24, 2017 U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Nov 21, 2017 OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... The device software versions have an anomaly which may produce an erroneous marking for the quali... Class II Oculus Optikgeraete GMBH
Nov 21, 2017 Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z ... It was discovered that the product units it imported may, at peak levels, emit radiation that ex... Class II SANTA JOY ORNAMENT & GIFTWARE CO
Nov 20, 2017 Agility with Integrity R3.2 Potential for positional errors following automatic table movement (ATM). Class II Elekta Limited
Nov 20, 2017 Integrity R1.2 Potential for positional errors following automatic table movement (ATM). Class II Elekta Limited
Nov 20, 2017 Phadia Prime software, article number 12-4101-00, as used in combination with... We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ... Class II Phadia Ab
Nov 20, 2017 RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul... Class II RAYSEARCH LABORATORIES AB
Nov 17, 2017 Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... Potential errors in patient results generated by the Screening Center product that include both f... Class II PerkinElmer Life and Analytical Sciences, Walla...
Nov 16, 2017 Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLin... Due to a human error at a supplier, an unknown number of devices within one specific production l... Class II Brainlab AG
Nov 10, 2017 Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. Internal program testing shows that product may not reach the indicated expiration date. Class II Wiener Laboratories
Nov 3, 2017 BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 462... Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly a... Class II Brainlab AG
Nov 2, 2017 NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... There is a potential for leaking vials for certain lot numbers where, if proper attire is not use... Class II PerkinElmer Life and Analytical Sciences, Walla...
Nov 2, 2017 pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 ... The firm received reports of two breakages of the pin tips which occurred during two identical su... Class II Pro-Med Instruments Gmbh
Nov 2, 2017 Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysi... The diagnostic test kit may produce invalid test runs which may delay test results. Class II Epigenomics Ag
Oct 30, 2017 CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the... Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after... Class II Sorin Group Deutschland GmbH
Oct 28, 2017 fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows aud... Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat... Class II NordicNeuroLab AS
Oct 19, 2017 Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy ... Range for the same energy could be different depending if the layer is the first layer of the ir... Class II Ion Beam Applications S.A.
Oct 18, 2017 NucliSENS Lysis Buffer Extended lot for RES 76675 Elute may become colored due to the residual presence of heme group origination from hemoglobin p... Class II BioMerieux SA
Oct 17, 2017 Proteus 235, graphite block 8 IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader Class II Ion Beam Applications S.A.
Oct 17, 2017 Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 ma... Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. Class II Southmedic, Inc.
Oct 16, 2017 Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... Class II Fukuda Denshi Co., Ltd.
Oct 16, 2017 Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remi... Beckman Coulter has identified that due to a software nonconformity in connection with a changed ... Class II Normand Informatique
Oct 11, 2017 Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... Class I Spacelabs Healthcare, Ltd.

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.