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Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Oct 16, 2013 Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog... Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ... Class II Microgenics Corp
Oct 16, 2013 Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for p... Lens was manufactured with incorrect raw material. Class II Bausch & Lomb Surgical, Inc.
Oct 16, 2013 Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio fr... Cutera received two adverse events associated with the edge of the electrode, when it was pressed... Class II Cutera, Inc.
Oct 16, 2013 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte... Class III Nanosphere, Inc.
Oct 15, 2013 ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark ... RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative b... Class II Radiometer America Inc
Oct 15, 2013 McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). When merging two patient records into one patient record using McKesson Radiology 12.0, the resul... Class II Mckesson Information Solutions LLC
Oct 15, 2013 Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upp... Labeling inconsistency Class II Teleflex Medical
Oct 15, 2013 Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor... One material batch used for production of the affected parts of the Synthes Material Mix were mix... Class II Synthes USA HQ, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva with FlatDetector The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Oct 14, 2013 VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure... Product is not approved or authorized for distribution in the US. Class II BioMerieux SA
Oct 14, 2013 Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Lib... Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result ... Class II Fresenius Medical Care Holdings, Inc.
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... Class II Philips Healthcare Informatics, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva II The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Oct 14, 2013 Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm... Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve f... Class II Synthes (USA) Products LLC
Oct 13, 2013 Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needl... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inn... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Va... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if ster... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 11, 2013 PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 4... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LA... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE L... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FEM HD ION (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM a... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSYS HERITAGE FEM STEM Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUB... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Bipolar liners and Multipolar cups with the following dimensions in MM (38, 3... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx o... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Oct 11, 2013 HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40,... GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings as... Class II GE Healthcare, LLC
Oct 11, 2013 US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Oct 11, 2013 INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes s... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Br... If the couch, with the footrest extension attached, is positioned where the table travel is withi... Class II Philips Medical Systems (Cleveland) Inc
Oct 11, 2013 I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM P... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE P... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes ... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 11, 2013 6 DEGREE COCR FEM HEAD 36 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP BON Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP MOD Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tube... An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in u... Class II Becton Dickinson & Co.
Oct 11, 2013 MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.

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.