All Recalls

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Coconut and Peanut.

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, and Wheat.

Undeclared milk

Pasta label declares semolina flour but does not declare wheat.

Pasta label declares semolina flour but does not declare wheat.

Pasta label declares semolina flour but does not declare wheat.

Undeclared sesame

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, and Wheat.

Product potentially contaminated with deer feces

Pasta label declares semolina flour but does not declare wheat.

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, and Sesame.

Out of Specification result observed in content uniformity testing

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible