Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by…
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on…
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
It was discovered that bottles of Brain and Memory Power Boost was filled with multi vitamin-mineral product - NeuroVite Plus
Sandwiches may contain undeclared soy and egg.
The firm was notified by one of their customers that during a random testing by ODA the product test positive for Listeria monocytogenes.
Undeclared sulfites
Sandwiches may contain undeclared egg.
Sandwiches may contain undeclared soy and egg.
Sandwiches may contain undeclared soy and egg.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Product Mix-up: Incorrect diluent component included in the kit.
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
