Recall database

Class II recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1,489–1,500 of 3,866 recalls

Class IIOngoingZ-0943-2026

Copan Italia recalls 1ml of DTT in liquid phase

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Copan ItaliaDec 24, 2025

Class IIOngoingZ-0942-2026

Copan Italia recalls 1ml of DTT in liquid phase

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Copan ItaliaDec 24, 2025

Class IIOngoingZ-0941-2026

DICOM Grid, Inc. recalls Intelerad InteleShare software

Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer;…

DICOM Grid, Inc.NCDec 24, 2025

Class IIOngoingZ-0940-2026

PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds.…

PATHDec 24, 2025

Class IIOngoingZ-0937-2026

SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide

The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments.…

SEASPINE ORTHOPEDICS C…CADec 24, 2025

Class IIOngoingZ-0936-2026

Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Fresenius Medical Care…MADec 24, 2025

Class IIOngoingZ-0935-2026

GE Healthcare GmbH recalls GE HealthCare ViewPoint 6

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.