Tennessee recalls

Device packaged in incorrect outer box carton.

Customer complaints of Pressio monitor rebooting.

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

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 clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

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. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

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. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

The affected lots show a decline in performance over time, which may lead to false-negative results.

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.

Potential for incomplete scan due to unstable connection inside of floating sensor.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

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 programs (OGPs) the collimation may be incorrect.

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 for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

pathogen Cyclospora cayetanensis

May contain partially hydrogenated oils

May contain partially hydrogenated oils

Potential contamination with Salmonella.

Out of specification for dissolution.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Presence of particulate matter - Glass like particles.

Presence of particulate matter - Glass like particles.

Presence of particulate matter - Glass like particles.

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

The pedal axle can crack, causing the pedal to detach from the crank, posing a fall hazard to the rider.

The chargers can explode while in use, posing a fire and burn hazard.