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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.

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DateProductReasonClassFirm
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Dec 6, 2016 CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: T... Accuray has become aware of a potential safety issue involving the possibility of electric shock ... Class II Accuray Incorporated
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 5, 2016 OPT Croutons is a synthetic bone substitute designed for the repair of bony d... OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of... Class II Acumed LLC
Dec 2, 2016 Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound... Reunion TSA Peg Alignment Sound broke during surgery. Class II Stryker Howmedica Osteonics Corp.
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
Dec 2, 2016 Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product ... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Dec 2, 2016 Foot Section - BAR5490IVC A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... Class II Invacare Corporation
Dec 2, 2016 Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/... During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. Class I CareFusion 303, Inc.
Dec 2, 2016 Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmen... Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces res... Class II Varian Medical Systems, Inc.
Dec 2, 2016 A1CNow+ Systems (professional use product), Software Version Revision D, REF ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Dec 2, 2016 Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage:... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Dec 2, 2016 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 K2M Special Connector Instruments (Special Connector, Special Adaptor, and Qu... Instruments were developed without adequate consideration given to the need for a new regulatory ... Class II K2M, Inc
Dec 2, 2016 A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 Bariatric Bed - BAR600IVC The junction box used in the bariatric bed may emit sparks and result in a fire. Class II Invacare Corporation
Dec 2, 2016 MOSAIQ Oncology Information System The product is used to manage workflow... Edits to Particle field definition parameters may not be saved when the field definition window i... Class II Elekta, Inc.
Dec 2, 2016 Junction Box - 1104343 and 1193560 A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... Class II Invacare Corporation
Dec 2, 2016 Bariatric Bed - BARPKG-IVC 1633 A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... Class II Invacare Corporation
Dec 1, 2016 Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular ... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing tran... Possibility that a patient or user may be exposed to a very small level of touch current. Class II Philips Electronics North America Corporation
Dec 1, 2016 TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobi... The interface between the TB3 back and tilt base can separate when tilted beyond the specified an... Class II Pride Mobility Products Corp
Dec 1, 2016 Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydr... Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dil... Class II Merit Medical Systems, Inc.
Dec 1, 2016 Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... Class II PerkinElmer Health Sciences, Inc.
Dec 1, 2016 Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-r... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Nov 30, 2016 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryk... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... Class III Ecolab Inc
Nov 30, 2016 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minim... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing le... Class II Boston Scientific Corporation
Nov 30, 2016 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating... ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a... Class II ICU Medical, Inc.
Nov 30, 2016 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryk... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A sin... A complaint of the PRO2 jaw breaking prior to surgery being performed. Class II AtriCure, Inc.
Nov 30, 2016 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 29, 2016 Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood ... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C1313... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... Class II Siemens Healthcare Diagnostics, Inc.
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 29, 2016 Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 ... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evac... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, 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.