All Recalls

The stiffness of the soft end of the guidewire caused tissue perforation.

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

The recalled chest is unstable if it is not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-19).

The popcorn's paper bag can catch fire in the microwave, posing fire and burn hazards.

The recalled magnet sets contain high-powered magnets and violate the federal standard for children's toys. When two or more high-powered magnets are swallowed, they can link together inside a child's intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects.

Product contains dried peaches, but front labeling of product stated dried plums

FDA sample analysis of Biotin 1000mg Lot #1345 showed the product Biotin content to be 0.8% of label claim.

May contain undeclared milk

Product may contain undeclared Milk (whey listed in ingredients)

Product contains undeclared sulfites.

Dark Chocolate mint bar contains undeclared milk

FDA sample analysis of Calci-Max lot 31453 showed the product zinc content to be 0.0% of label claim.

Product may contain undeclared Wheat, Soy, Eggs, and Milk

Unsalted butter has potential to be contaminated with Listeria monocytogenes.