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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1134

29,496 detailed records are currently available in this category.

Medical DeviceNov 25, 2015

Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal recall — FDA Z-0291-2016

Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with…

Class IIIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceNov 25, 2015

Ameditech DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D recall — FDA Z-0309-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Ameditech DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D recall — FDA Z-0307-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed recall — FDA Z-0274-2016

Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.

Class IIFDA: TerminatedHill-Rom, Inc.

Medical DeviceNov 25, 2015

Ameditech Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No recall — FDA Z-0312-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software recall — FDA Z-0282-2016

Instances of data sets not being accurately registered to the patient anatomy were observed.

Class IIFDA: TerminatedBrainlab AG

Medical DeviceNov 25, 2015

Ameditech ProScreen 10 Drug Panel Cassette Test, Item No recall — FDA Z-0315-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Medacta Usa GMK Hinge knee prosthesis recall — FDA Z-0275-2016

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

Class IIFDA: TerminatedMedacta Usa

Medical DeviceNov 25, 2015

Ameditech The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No recall — FDA Z-0316-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Ameditech Premier Clia Waived 12 panel Tilt Cup, Item No recall — FDA Z-0314-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Philips Electronics ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and recall — FDA Z-0273-2016

When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences…

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceNov 25, 2015

Astora MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261 recall — FDA Z-0279-2016

The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed…

Class IIFDA: TerminatedAstora

Medical DeviceNov 25, 2015

Roche Diagnostics Operations Bulk Loader Module for cobas p 512/612 Pre-analytical sample recall — FDA Z-0297-2016

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceNov 25, 2015

Ameditech DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are recall — FDA Z-0305-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Ameditech 1 Step 12 Panel Cup, Item No recall — FDA Z-0298-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Ameditech DrugCheck Waived 12 Panel Cup w/Adult, Item No recall — FDA Z-0306-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Ameditech iCup Drug Screen Cup, Item No recall — FDA Z-0311-2016

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Class IIFDA: TerminatedAmeditech Inc.

Medical DeviceNov 25, 2015

Leonhard Lang Medizintechnik GmbH ECG Electrodes: 50007 Stablebase SBW55 50675 recall — FDA Z-0292-2016

There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the…

Class IIFDA: TerminatedLeonhard Lang Medizintechnik GmbH

Medical DeviceNov 25, 2015

TZ Medical Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following recall — FDA Z-0293-2016

The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal

Class IIFDA: TerminatedTZ Medical Inc.

Medical DeviceNov 25, 2015

AGFA Healthcare IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and recall — FDA Z-0283-2016

Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.

Class IIFDA: TerminatedAGFA Healthcare Corp.

Medical DeviceNov 18, 2015

WalkMed Infusion Triton Infusion Pump (model 300000) and Triton fp Infusion Pump recall — FDA Z-0242-2016

The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the…

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceNov 18, 2015

Boston Scientific RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation recall — FDA Z-0211-2016

Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational…

Class IFDA: TerminatedBoston Scientific Corporation

Medical DeviceNov 18, 2015

Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC recall — FDA Z-0262-2016

MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the…

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceNov 18, 2015

Biocare Medical Smooth Muscle Action (SMA) Immunohistochemistry reagent recall — FDA Z-0252-2016

Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.

Class IIFDA: TerminatedBiocare Medical, LLC

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.