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Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Dec 17, 2014 CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in ske... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implan... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, ... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 Miethke Shunt System accessories Product Usage: - The Miethke Shunt Syst... Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box lab... Class II Aesculap, Inc.
Dec 17, 2014 Metasul Femoral Head - A modular head component is used in conjunction with a... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 Metasul Femoral Head - indicated for total hip arthroplasty for treatment of... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 CoCr Femoral Head - A modular head component is used in conjunction with a fe... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 16, 2014 ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following mach... Unqualified power assemblies shipped to customers. Class II Fresenius Medical Care Holdings, Inc.
Dec 16, 2014 ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x... Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a ... Class II Siemens Healthcare Diagnostics, Inc.
Dec 16, 2014 Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh... The staining intensity decreases over the shelf life. Class II Leica Microsystems, Inc.
Dec 16, 2014 CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and... Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration u... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 16, 2014 Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POS... the Instructions for Use (IFU) were inadvertently removed from the kit. Class II Arrow International Inc
Dec 15, 2014 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E ... Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-... Class II Stryker Howmedica Osteonics Corp.
Dec 15, 2014 Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Int... Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is... Class II Synthes, Inc.
Dec 15, 2014 Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits... Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead ... Class II Genetic Testing Institute,inc
Dec 15, 2014 Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... Potential for composed images to be flipped before being sent to PACS on systems with software v... Class II Siemens Medical Solutions USA, Inc
Dec 15, 2014 nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... Class II NordicNeuroLab AS
Dec 15, 2014 Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Malleable C- Retractor, Part Number 397.232, used to provide retraction of th... Potential failure and/or corrosion of the internal spring of the retractor, which may have been m... Class II Synthes, Inc.
Dec 15, 2014 Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 14, 2014 Juno DFR X-ray system The system does not provide the appropriate audible signal, permanent activation, and manual over... Class II Villa Radiology Systems LLC
Dec 12, 2014 R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... Class II Teleflex, Inc.
Dec 12, 2014 MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product U... Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over t... Class II Biocare Medical Llc
Dec 12, 2014 Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... Class III Pointe Scientific, Inc.
Dec 11, 2014 Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pai... The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class II Med Tec Inc
Dec 11, 2014 MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Bre... The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect.... Class II Mentor Texas, LP.
Dec 11, 2014 Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots ... Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of s... Class II Zimmer, Inc.
Dec 11, 2014 Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN... The dials in the Autopens are not working - the dial does not stay dialed, but springs right back... Class II Owen Mumford USA, Inc.
Dec 11, 2014 Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-s... The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class II Med Tec Inc
Dec 10, 2014 Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... Class I Covidien
Dec 10, 2014 The I-Cart is used to store, transport, and power video equipment used in med... The transformers installed on carts used for Richard Wolf medical video systems may overheat caus... Class II Richard Wolf Medical Instruments Corp.
Dec 10, 2014 GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : ... Potential unintentional system motion or rotation due to a positioning user interface issue with ... Class II GE Healthcare
Dec 10, 2014 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting a... Customer complaint indicating the color bands on the MIA16-G1 were not correct. Class II The Anspach Effort, Inc.
Dec 10, 2014 Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, ... A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... Class I Covidien
Dec 8, 2014 iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro... Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive l... Class II Beckman Coulter Inc.
Dec 8, 2014 ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer th... The ABL90 analyzer does not always use the most recent calibration data to calculate patient resu... Class II Radiometer America Inc
Dec 8, 2014 Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit ... Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. Class II Philips Medical Systems (Cleveland) Inc
Dec 8, 2014 Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomograph... There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Im... Class II Mobius Imaging, LLC
Dec 8, 2014 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... Class II Baxter Healthcare Corp.
Dec 8, 2014 Osteobond Bone Cement Bone cement monomer is kitted with bone cement powde... Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between ... Class II Zimmer, Inc.
Dec 8, 2014 GE Healthcare, Proteus XR/a with wall stand model number 600-0301. GE Healthcare has recently become aware of a potential safety issue involving the breakage of the... Class II GE Healthcare
Dec 5, 2014 Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial inse... Presence of one inoperable (dead) sensor pad. Class II Orthosensor, Inc.
Dec 5, 2014 INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 G- Series Beds; G29 full length bed rails assembly Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of spe... Class II Invacare Corporation
Dec 5, 2014 IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgic... Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vi... Class II Intuitive Surgical, Inc.
Dec 4, 2014 DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone vo... The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above ma... Class II Musculoskeletal Transplant Foundation, 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.