Latest Product Recalls Today

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Potential Salmonella contamination.

Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.

Foreign material (aluminum pieces).

Foreign material (aluminum pieces).

Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy.

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Potential adulteration with erucic acid from mustard oil ingredient.

Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.

Potential Salmonella contamination.

Product may contain foreign material (metal fragments).

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Foreign material (aluminum pieces).

Product may contain foreign material (metal fragments).

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy