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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.

30,447medical device recall records

2,766FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1217

30,447 detailed records are currently available in this category.

Medical DeviceJan 21, 2015

Med Tec Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile recall — FDA Z-0989-2015

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

Class IIFDA: TerminatedMed Tec Inc.

Medical DeviceJan 21, 2015

GE Healthcare recall — FDA Z-0954-2015

GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray…

Class IIFDA: TerminatedGE Healthcare

Medical DeviceJan 21, 2015

Brainlab AG iPlan RT is a radiation treatment planning system that is intended for use in recall — FDA Z-0957-2015

iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

Class IIFDA: TerminatedBrainlab AG

Medical DeviceJan 21, 2015

Philips Medical Systems HeartStart MRx Monitor/Defibrillator recall — FDA Z-0963-2015

Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceJan 21, 2015

Siemens Medical Solutions USA Symbia T and Symbia T2 computer tomography systems recall — FDA Z-0960-2015

There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceJan 21, 2015

Synthes Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft recall — FDA Z-0973-2015

Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could…

Class IIFDA: TerminatedSynthes, Inc.

Medical DeviceJan 21, 2015

Becton Dickinson & Co TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II recall — FDA Z-0974-2015

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon…

Class IIFDA: TerminatedBecton Dickinson & Co.

Medical DeviceJan 21, 2015

Biocare Medical MUM-1 recall — FDA Z-0965-2015

Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

Class IIFDA: TerminatedBiocare Medical LLC

Medical DeviceJan 21, 2015

Biomet Spine Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205 recall — FDA Z-0983-2015

The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable…

Class IIFDA: TerminatedBiomet Spine, LLC

Medical DeviceJan 21, 2015

Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD recall — FDA Z-0967-2015

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceJan 21, 2015

Siemens Medical Solutions USA SOMATOM Force; the intended use of computed tomography is to recall — FDA Z-0971-2015

Artifacts are found in acquired imaging on the SOMATOM Force.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceJan 21, 2015

Becton Dickinson & Co Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is recall — FDA Z-0976-2015

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon…

Class IIFDA: TerminatedBecton Dickinson & Co.

Medical DeviceJan 21, 2015

Intertrade Imports Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm recall — FDA Z-0950-2015

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved…

Class IIFDA: TerminatedIntertrade Imports Inc.

Medical DeviceJan 21, 2015

Becton Dickinson & Co CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is recall — FDA Z-0975-2015

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon…

Class IIFDA: TerminatedBecton Dickinson & Co.

Medical DeviceJan 21, 2015

GE OEC Medical Systems GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general recall — FDA Z-0841-2015

mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum…

Class IIFDA: TerminatedGE OEC Medical Systems, Inc.

Medical DeviceJan 21, 2015

Ortho-Clinical Diagnostics VITROS 4600 Chemistry System recall — FDA Z-0968-2015

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceJan 21, 2015

Abbott Molecular The Abbott m2000sp is an automated system for performing sample preparation recall — FDA Z-0948-2015

The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.

Class IIFDA: TerminatedAbbott Molecular

Medical DeviceJan 21, 2015

Tecan US Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with recall — FDA Z-0992-2015

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Class IIIFDA: TerminatedTecan US, Inc.

Medical DeviceJan 21, 2015

Stryker Instruments Div. of Stryker The SurgiCounter Charging Cradle Product Usage recall — FDA Z-0986-2015

Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceJan 21, 2015

Straumann USA Drill set long, drill stop compatible for 4.8mm diameter implant, Article recall — FDA Z-0981-2015

Drill set may contain incorrect drill.

Class IIFDA: TerminatedStraumann USA, LLC

Medical DeviceJan 21, 2015

Biomet Spine Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model recall — FDA Z-0982-2015

The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.

Class IIFDA: TerminatedBiomet Spine, LLC

Medical DeviceJan 21, 2015

Siemens Healthcare Diagnostics ADVIA Chemistry XPT interfaced to the CentraLink Data recall — FDA Z-0987-2015

Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJan 21, 2015

Siemens Medical Solutions USA Artis Q, and Artis Q.zen ceiling systems recall — FDA Z-0972-2015

Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceJan 21, 2015

Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Catalog Number 6802413, IVD recall — FDA Z-0969-2015

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIFDA: TerminatedOrtho-Clinical Diagnostics

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.