All Recalls

Inflation device handle may detach from the syringe during procedure.

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

Product tested high for lead.

elevated levels of aflatoxin

Products may be contaminated with Salmonella Richmond.

undeclared soy, wheat, milk

Undeclared Soy. Label did not include soy, which was used in product.

undeclared hazelnut.

Potential undeclared allergen ingredient (Wheat)

Product tested high for lead.

Unapproved color (carmoisine).

Undeclared Soy. Label did not include soy, which was used in product.

Undeclared tree nut allergens: almonds, pecans, and walnuts.

Undeclared Soy. Label did not include soy, which was used in product.

elevated levels of chloramphenicol in frozen shrimp

Undeclared soy lecithin

Undeclared Fish and Egg Allergen