All Recalls

The recalled unassembled Deluxe Pit Kit slot cars violate the mandatory federal regulation for magnets because the magnets used to power the car are loose prior to assembly, posing an ingestion hazard to children. Assembled models do not pose this risk and are therefore not subject to this recall. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

Undeclared milk

Product may contain egg, an undeclared allergen.

Undeclared milk

Undeclared Yellow #5

Undeclared milk

Firm received complaints of infant choking.

Potato flour item #20501 was recalled due to undeclared milk (between 13ppm and 17ppm).

Mislabeled salads (undeclared peanut allergen). Incorrect ingredient applied (peanuts)

Firm received complaints of infant choking.

Undeclared Yellow #5

Product may be contaminated with foreign objects (white fragments of plastic, varying in length and width).

Small pieces of plastic broken tray in the product.

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.