Abiomed Automated Impella Controller (AIC), used in left heart support blood pump, including recall — FDA Z-2164-2025
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Complete FDA and NHTSA recall records dated in August 2025.
These records include useful source details for the selected month.
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.
allergen labeling - undeclared milk
Multiple cake products contain goat milk, which was labeled as "milk"
Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary…
Multiple cake products contain goat milk, which was labeled as "milk"
Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary…
Multiple cake products contain goat milk, which was labeled as "milk"
Multiple cake products contain goat milk, which was labeled as "milk"
Multiple cake products contain goat milk, which was labeled as "milk"
Multiple cake products contain goat milk, which was labeled as "milk"
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary…
Multiple cake products contain goat milk, which was labeled as "milk"
Multiple cake products contain goat milk, which was labeled as "milk"
Multiple cake products contain goat milk, which was labeled as "milk"
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary…
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity,…
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
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.