Class IIOngoingZ-1029-2026
Sophysa recalls The Pressio 2 ICP Monitoring System
Customer complaints of Pressio monitor rebooting.
SophysaJan 14, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,417–1,428 of 3,866 recalls
Class IIOngoingZ-1028-2026
CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
CareFusion 303, Inc.CAJan 14, 2026
Class IIOngoingZ-1027-2026
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy.…
Remote Diagnostic Tech…Jan 14, 2026
Class IIOngoingZ-1026-2026
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 800
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts.…
Beckman Coulter, Inc.MNJan 14, 2026
Class IIOngoingZ-1025-2026
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts.…
Beckman Coulter, Inc.MNJan 14, 2026
Class IIOngoingZ-1019-2026
Meridian Bioscience Inc recalls Revogene C. difficile
The affected lots show a decline in performance over time, which may lead to false-negative results.
Meridian Bioscience In…OHJan 14, 2026
Class IIOngoingZ-1010-2026
Applied Medical Resources Corp recalls Kii Low Profile
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Applied Medical Resour…CAJan 14, 2026
Class IIOngoingZ-1009-2026
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptav…
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Roche Diagnostics Oper…INJan 14, 2026
Class IIOngoingZ-1003-2026
Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
Philips Healthcare (Su…Jan 14, 2026
Class IIOngoingZ-0999-2026
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ prog…
Siemens Medical Soluti…PAJan 14, 2026
Class IIOngoingZ-0998-2026
Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s camera…
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use fo…
Vision RT LtdJan 14, 2026
Class IIOngoingZ-1008-2026
Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended.…
Beaver-Visitec Interna…MAJan 7, 2026