Complete FDA and NHTSA recall records dated in September 2018.
These records include useful source details for the selected month.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The product may be contaminated with Listeria monocytogenes.
Product contains undeclared allergens, egg, crustacean, and pork.
Product contains undeclared allergens egg and crustacean.
Potential for cleaning chemical introduced into product due to process deviation while cleaning pasteurizer.
During FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the allergen statement
During FDA foreign inspection of manufacturer, it was discovered that milk, wheat and soy were not declared as sub ingredients or in the allergen statement
The firm was notified by a customer that mold was in the product.
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
