Complete FDA and NHTSA recall records dated in October 2021.
These records include useful source details for the selected month.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Error in the device firmware results in the inaccurate detection of device position.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially…
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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.
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.
