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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,963medical device recall records

2,598FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1175

29,963 detailed records are currently available in this category.

Medical DeviceJul 22, 2015

Elekta MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to recall — FDA Z-2063-2015

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceJul 22, 2015

Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is recall — FDA Z-2070-2015

Shipped to a single consignee prior to completion of final inspection.

Class IIFDA: TerminatedExactech, Inc.

Medical DeviceJul 22, 2015

Northern Digital NDI Disposable Reflective Marker Spheres for Brainlab IGS recall — FDA Z-2084-2015

Inadequate curing of adhesive, may cause the two halves of the spheres to separate.

Class IIFDA: TerminatedNorthern Digital Inc.

Medical DeviceJul 22, 2015

Synthes Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies recall — FDA Z-2092-2015

It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added…

Class IIFDA: TerminatedSynthes, Inc.

Medical DeviceJul 22, 2015

Eizo RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC recall — FDA Z-2088-2015

EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

Class IIFDA: TerminatedEizo Corporation

Medical DeviceJul 22, 2015

Northern Digital NDI Disposable Reflective Marker Spheres for Brainlab IGS recall — FDA Z-2093-2015

Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

Class IIFDA: TerminatedNorthern Digital Inc.

Medical DeviceJul 22, 2015

Viewray Patient Handling System (Motion Control Software), Product Usage: Indicated for recall — FDA Z-2085-2015

ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.

Class IIFDA: TerminatedViewray Inc.

Medical DeviceJul 22, 2015

Alere i flu, Alere i, Alere Influenza A & B recall — FDA Z-2095-2015

Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit

Class IIFDA: TerminatedAlere Scarborough, Inc. dba Binax, Inc.

Medical DeviceJul 22, 2015

Eizo RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180 recall — FDA Z-2089-2015

EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

Class IIFDA: TerminatedEizo Corporation

Medical DeviceJul 22, 2015

Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal recall — FDA Z-2078-2015

Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceJul 22, 2015

Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal recall — FDA Z-2079-2015

Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceJul 22, 2015

AGFA Healthcare IMPAX Agility. IMPAX Agility when deployed as a departmental Picture recall — FDA Z-2061-2015

Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

Class IIFDA: TerminatedAGFA Healthcare Corp.

Medical DeviceJul 22, 2015

Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal recall — FDA Z-2081-2015

Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceJul 22, 2015

BD Biosciences, Systems & Reagents BD Flow Cytometers recall — FDA Z-2090-2015

Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC…

Class IIIFDA: TerminatedBD Biosciences, Systems & Reagents

Medical DeviceJul 22, 2015

Synthes (USA) Products 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate recall — FDA Z-2086-2015

It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceJul 22, 2015

Biomet A.L.P.S. - Medium Bone Plate Forceps recall — FDA Z-2072-2015

Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

Class IIFDA: TerminatedBiomet, Inc.

Medical DeviceJul 22, 2015

Stryker Instruments Div. of Stryker 0210-312-000-Woundcare Replacement kit with soft tip recall — FDA Z-2062-2015

Potential sterility breach in the packaging.

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceJul 22, 2015

Nidek Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek recall — FDA Z-2067-2015

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Class IIFDA: TerminatedNidek Inc.

Medical DeviceJul 22, 2015

Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have recall — FDA Z-2073-2015

The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become…

Class IIFDA: TerminatedEtac Supply Center Ab

Medical DeviceJul 22, 2015

Synthes (USA) Products Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA) recall — FDA Z-2091-2015

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceJul 22, 2015

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care recall — FDA Z-2094-2015

Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound,…

Class IIFDA: TerminatedBreas Medical AB

Medical DeviceJul 22, 2015

Maquet Cardiovascular Us Sales The FLOW-i Anesthesia System Axillary O2 and Suction Module recall — FDA Z-2083-2015

Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch…

Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC

Medical DeviceJul 22, 2015

Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal recall — FDA Z-2077-2015

Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceJul 22, 2015

Biomet Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide recall — FDA Z-2065-2015

Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.

Class IIFDA: TerminatedBiomet, Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.