Complete FDA and NHTSA recall records dated in January 2026.
These records include useful source details for the selected month.
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…
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…
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base…
The affected lots show a decline in performance over time, which may lead to false-negative results.
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head…
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…
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…
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of…
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
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…
Product tested positive for Listeria Monocytogenes.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Product tested positive for Listeria Monocytogenes.
Foreign material.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Potential contamination with Salmonella.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Floating black foreign substance in the product
Foreign material.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
