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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
May 12, 2016 COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 12, 2016 iGUIDE System, for patient positioning, with assistance of a 30 Tracking Syst... If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the... Class II Elekta, Inc.
May 12, 2016 COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 11, 2016 Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bon... DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... Class II Synthes (USA) Products LLC
May 11, 2016 Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bon... DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... Class II Synthes (USA) Products LLC
May 11, 2016 Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 1044480... Premature bucket failures Class II Siemens Healthcare Diagnostics Inc.
May 11, 2016 Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Inst... Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instrument... Class II Zimmer Biomet, Inc.
May 11, 2016 Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bo... DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... Class II Synthes (USA) Products LLC
May 11, 2016 Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of... There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup... Class II Medline Industries Inc
May 10, 2016 TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Scre... As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Ga... Class II Integra LifeSciences Corp.
May 10, 2016 Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa... Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Load... Class II Fujifilm Medical Systems U.S.A., Inc.
May 10, 2016 Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for... Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal ... Class II CarboFix Orthopedics, Ltd.
May 10, 2016 SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R... Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue n... Class II Cell Marque Corporation
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 9, 2016 Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal ... The device was found to have bacterial contamination. Class II Immuno-Mycologics, Inc
May 9, 2016 Optima 1.5T MR430s MR Scanner, a diagnostic imaging device The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... Class II GE Healthcare, LLC
May 9, 2016 MSK 1.5T Extreme MR Scanner, a diagnostic imaging device The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... Class II GE Healthcare, LLC
May 9, 2016 GE Revolution CT The system is intended for head, whole body, cardiac and ... GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can res... Class II GE Healthcare, LLC
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 Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists ... Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during proc... Class II Medtronic Navigation, Inc.
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 9, 2016 cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead of the pcal/gain set... Class II Roche Molecular Systems, Inc.
May 9, 2016 Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Set... Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of ... Class II Datascope Corporation
May 9, 2016 Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... Software error in previous software versions in which two references for the same image may exist... Class II Siemens Medical Solutions USA, Inc
May 6, 2016 Endotine Transbleph 3.5 (CFD-080-0167) MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167),... Class II MicroAire Surgical Instruments, LLC
May 6, 2016 The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneo... To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleani... Class II Custom Ultrasonics, 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 6, 2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Chan... A diode was inadvertently not assembled into the system, which may result in coil overheating Class II Invivo Corporation
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 Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individua... This recall has been initiated due to the product labeled with the incorrect expiration date. Class II Medical Components, Inc dba MedComp
May 5, 2016 The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration... Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... Class III Siemens Healthcare Diagnostics, Inc.
May 5, 2016 Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.... The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a... Class II Teleflex Medical
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 The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Am... Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... Class III Siemens Healthcare Diagnostics, Inc.
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 5, 2016 Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Powe... Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either t... Class II Stryker Medical Division of Stryker Corporation
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.
May 4, 2016 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fu... 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.
May 4, 2016 Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Len... 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.
May 4, 2016 ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. ... Due to a suspected misalignment of the connection between the proximal balloon cap of the implant... Class II Reshape Medical Inc
May 4, 2016 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 4... 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.
May 4, 2016 Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Len... 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.
May 4, 2016 Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabu... 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.
May 4, 2016 Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm... 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.
May 4, 2016 Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
May 4, 2016 Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 m... 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.
May 4, 2016 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head,... 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.
May 4, 2016 Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
May 4, 2016 Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone... 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.

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.