Straumann Custom Abutments
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.
2 productsA material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.
2 productsConvatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.
3 productsOmnipod 5 Pods may have a tear causing insulin to leak inside, leading to under-delivery or cessation of insulin.
BZK Antiseptic Towelettes have CGMP deviations.
21 productsReason given by FDA: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution.
2 productsThe Octopus Nuvo Tissue Stabilizer has tubing incorrectly positioned, which may cause assembly issues.
Bisoprolol Fumarate and Hydrochlorothiazide tablets fail to meet impurity specification limits.
The Aquarion Preserved Cartridges have cGMP deviations.