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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

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
Feb 11, 2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... Class II Zimmer Biomet, Inc.
Feb 9, 2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... A report can be confirmed with the incorrect patient demographics resulting in it being saved und... Class II Merge Healthcare, Inc.
Feb 9, 2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... Class II Medtronic Neuromodulation
Feb 8, 2016 TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... Class II Ormco/Sybronendo
Feb 5, 2016 Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... Class II Beckman Coulter Inc.
Feb 5, 2016 Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... When measuring a lesion on an unmagnified mammography image then performing the same measurement ... Class II Merge Healthcare, Inc.
Feb 3, 2016 PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single U... Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit,... Class II Medical Action Industries Inc
Jan 31, 2016 Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... Potential data loss occurs as a result of product archiving not working properly. Class II Merge Healthcare, Inc.
Jan 31, 2016 RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down ... Class II Merge Healthcare, Inc.
Jan 30, 2016 RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... Class II Merge Healthcare, Inc.
Jan 30, 2016 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... A migrated study that has annotations will display the annotations, but when a prior study is loa... Class II Merge Healthcare, Inc.
Jan 30, 2016 Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... Potential data loss occurs as a result of the software archiving not working properly. Class II Merge Healthcare, Inc.
Jan 30, 2016 Merge PACS software. Product was distributed under the AMICAS label, Brighto... The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. Class II Merge Healthcare, Inc.
Jan 30, 2016 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. Class II Merge Healthcare, Inc.
Jan 30, 2016 CADstream software. The firm name on the label is Merge Healthcare, Hartland... The software was not presenting the PURE filter user interface message on DICOM transfer studies.... Class II Merge Healthcare, Inc.
Jan 30, 2016 iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, ... Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... Class II Merge Healthcare, Inc.
Jan 29, 2016 Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. ... It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from star... Class II Valeant Pharmacueticals International
Jan 27, 2016 UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consi... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 27, 2016 Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral ... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 26, 2016 AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SIN... The firm received complaints that the product is shorter in length than indicated on the label. Class II Applied Medical Technology Inc
Jan 25, 2016 BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... Class III Becton, Dickinson and Company, BD Biosciences
Jan 22, 2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... Class II 3M Company - Health Care Business
Jan 21, 2016 EkoSonic Endovascular System, Catalog Number 500-56112. It consists of thr... The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug... Class II EKOS Corporation
Jan 20, 2016 Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. Class II Zimmer Biomet, Inc.
Jan 20, 2016 Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. Class II Cook Inc.
Jan 19, 2016 CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe... The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI... Class III Sorin Group USA, Inc.
Jan 18, 2016 Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... On the label calcium (Ca) listed in the right upper corner of the label (red background) incorre... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jan 15, 2016 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Powe... The product is labeled with an expiration date that is past its shelf life. Class II Spectranetics Corp.
Jan 15, 2016 Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... Customers reported issues when scanning medications with the scanners. When a user scans a medic... Class II CareFusion 303, Inc.
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Jan 5, 2016 Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. I... Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product ... Class II Bard Peripheral Vascular Inc
Jan 5, 2016 Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. I... Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm ... Class II Bard Peripheral Vascular Inc
Dec 29, 2015 PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Pr... Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) Class II Pharmacaribe llc
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... Class II Stryker Howmedica Osteonics Corp.
Dec 21, 2015 Hip Preservation System Signature Series PreBent Burs under the following lab... Metal shavings released from burs during use are due to contact between the bur and the hood of t... Class II ConMed Corporation
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for u... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bla... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Co... This Lot is not meeting labeled on-board instrument stability claims of 5 days. Class II Instrumentation Laboratory Co.
Dec 17, 2015 Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Mo... Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single p... Class II Stryker Sustainability Solutions
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
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 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wiz... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 347... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 T... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wiz... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer

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.