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
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further…
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
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…
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…
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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
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.
