Latest Product Recalls Today

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.

A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

There is the potential for the length of the trocar shaft to be too long.

Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Potential for rubber fragment detachment during use.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Potential for rubber fragment detachment during use.

Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).

Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.

Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).

Product may contain undeclared peanuts.

Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.

Products contain undeclared milk and soy.

Potential contamination with patulin.

Products contain undeclared milk and soy.

Volvo Car USA, LLC (Volvo Car) is recalling certain 2025-2026 EX30 and 2026 EX30CC vehicles. The seat belt warning system may not activate the audible warning chime as intended. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection." An audible warning chime that does not properly alert of an unbelted seat belt can increase the risk of injury during a crash.

ARBOC Specialty Vehicles, LLC (ARBOC) is recalling certain 2018-2026 Spirit of Freedom and Spirit of Mobility transit buses. The rear brake lines may have been installed incorrectly causing the anti-lock brake system (ABS) modulator valve to malfunction. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 105, "Hydraulic and Electric Brake Systems." Loss of the rear ABS system can increase the risk of a crash.