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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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1008

28,535 detailed records are currently available in this category.

Medical DeviceNov 30, 2016

Philips Healthcare System X-ray Tomography Computed recall — FDA Z-0375-2017

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceNov 30, 2016

Bausch & Lomb Inc Irb PeroxiClear Peroxide Solution recall — FDA Z-0651-2017

Product was found to contain excess residual levels of hydrogen peroxide.

Class IIFDA: TerminatedBausch & Lomb Inc Irb

Medical DeviceNov 30, 2016

Merit Medical Systems Fluid Management Set recall — FDA Z-0631-2017

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

Toshiba American Medical Systems Aquilion Prime TSX-303A Aquilion PRIME is a multislice recall — FDA Z-0622-2017

Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item recall — FDA Z-0628-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm recall — FDA Z-0625-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Merit Medical Systems Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer recall — FDA Z-0649-2017

Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

Depuy Orthopaedics ACTIS Flex Reamers SZ 0/1 recall — FDA Z-0650-2017

DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

Class IIFDA: TerminatedDepuy Orthopaedics Inc.

Medical DeviceNov 23, 2016

ICU Medical CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure recall — FDA Z-0519-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

C.R. Bard Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R recall — FDA Z-0406-2017

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Class IIFDA: TerminatedC.R. Bard, Inc.

Medical DeviceNov 23, 2016

Sorin Group USA The ORCHESTRA PLUS Programmer A portable device, equipped with a recall — FDA Z-0413-2017

Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings recall — FDA Z-0569-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Inpeco S.A FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to recall — FDA Z-0587-2017

Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.

Class IIFDA: TerminatedInpeco S.A.

Medical DeviceNov 23, 2016

ICU Medical TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV recall — FDA Z-0524-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item recall — FDA Z-0494-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" recall — FDA Z-0447-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE recall — FDA Z-0430-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO recall — FDA Z-0482-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The recall — FDA Z-0459-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical KIT FOR UNIVERSITY OF MICH recall — FDA Z-0462-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH recall — FDA Z-0417-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH recall — FDA Z-0440-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The recall — FDA Z-0514-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. recall — FDA Z-0456-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, 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.