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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 1017

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

Medical DeviceNov 23, 2016

Atrium Medical 24 Fr Trocar catheter, Sterile recall — FDA Z-0581-2017

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceNov 23, 2016

ICU Medical KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The recall — FDA Z-0477-2017

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 TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP recall — FDA Z-0464-2017

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 OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG recall — FDA Z-0474-2017

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 SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG recall — FDA Z-0521-2017

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 16, 2016

Baxter Healthcare GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product recall — FDA Z-0370-2017

Potential presence of particulate matter on the blood side of the dialyzer

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceNov 16, 2016

Covidien Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove recall — FDA Z-0366-2017

Added Instructions for Use: After application, inspect the Light Glove for barrier integrity

Class IIFDA: TerminatedCovidien LLC

Medical DeviceNov 16, 2016

Medimaps Group TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device recall — FDA Z-0369-2017

The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.

Class IIFDA: TerminatedMedimaps Group

Medical DeviceNov 16, 2016

Hospira Symbiq Two Channel Infuser recall — FDA Z-0362-2017

May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceNov 16, 2016

Micro Therapeutics Inc., Dba Ev3 Neurovascular Pipeline Embolization Device recall — FDA Z-0307-2017

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Class IFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular

Medical DeviceNov 16, 2016

Micro Therapeutics Inc., Dba Ev3 Neurovascular Alligator Retrieval Device The device is recall — FDA Z-0308-2017

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Class IFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular

Medical DeviceNov 16, 2016

Micro Therapeutics Inc., Dba Ev3 Neurovascular X-Celerator Hydrophilic Exchange Guidewire recall — FDA Z-0310-2017

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Class IFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular

Medical DeviceNov 16, 2016

Trumpf Medical Systems OR Table, Top U26 H V, Model # 1909793 recall — FDA Z-0391-2017

Trumpf has identified six incidents of pinched cables.

Class IIFDA: TerminatedTrumpf Medical Systems, Inc.

Medical DeviceNov 16, 2016

ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No recall — FDA Z-0392-2017

ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.

Class IIFDA: TerminatedReshape Medical Inc.

Medical DeviceNov 16, 2016

Maquet Medical Systems USA Accessory Adapter Part number 600525A0 Product Usage: designed recall — FDA Z-0390-2017

Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the…

Class IIFDA: TerminatedMaquet Medical Systems USA

Medical DeviceNov 16, 2016

Hospira Symbiq One Channel Infuser recall — FDA Z-0361-2017

May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The…

Class IIFDA: TerminatedHospira Inc.

Medical DeviceNov 16, 2016

Abbott Laboratories ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for recall — FDA Z-0379-2017

Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

Class IIFDA: TerminatedAbbott Laboratories

Medical DeviceNov 16, 2016

Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use recall — FDA Z-0387-2017

cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceNov 16, 2016

C.R. Bard X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE recall — FDA Z-0363-2017

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

Class IIFDA: TerminatedC.R. Bard, Inc.

Medical DeviceNov 16, 2016

Stryker Howmedica Osteonics LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment recall — FDA Z-0378-2017

Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceNov 16, 2016

Akita Sumitomo Bakelite Co SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working recall — FDA Z-0389-2017

Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

Class IIFDA: TerminatedAkita Sumitomo Bakelite Co., Ltd.

Medical DeviceNov 16, 2016

Akita Sumitomo Bakelite Co SB Knife -Electrosurgical Knife, Sterile Size: Working Length recall — FDA Z-0388-2017

Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long

Class IIFDA: TerminatedAkita Sumitomo Bakelite Co., Ltd.

Medical DeviceNov 16, 2016

AtriCure AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used recall — FDA Z-0377-2017

There is a potential for a component failure of the device which could necessitate medical intervention.

Class IIFDA: TerminatedAtriCure, Inc.

Medical DeviceNov 16, 2016

Schaerer Medical USA Replacement floor locking cylinders for the Schaerer model 7300 recall — FDA Z-0372-2017

The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to…

Class IIFDA: TerminatedSchaerer Medical USA 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.