American Contract Systems Various Pacemaker Packs, Cardio Thoracic Packs recall — FDA Z-1691-2022
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of…
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the…
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of…
Possible undeclared Walnuts. Undeclared Yellow #5, Yellow #6 and Red #40.
Undeclared Soy, Yellow #5, Yellow #6, Blue #1, Red #3, and Red #40
Undeclared Soy, Yellow #5, Yellow #6, Red #40
Possible undeclared Walnuts. Undeclared Red #40.
Undeclared Soy, Yellow #5, Yellow #6 and Red #40
Label declares Worcestershire Sauce but does not declare sub-ingredient fish (anchovy). The dressing, which contains Worcestershire sauce and sub-ingredient anchovy, is packaged in a small…
Ingredient used to manufacture pretzel products may have been contaminated with Cronobacter sakazakii, and/or Clostridium botulinum.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Microbial Contamination of Non-Sterile Products
Browse recent months with enough recall history for useful comparison.