Coltene Whaledent CEI Cutting Edge Instruments (PTC-57C) recall — FDA Z-0467-2021
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Complete FDA and NHTSA recall records dated in 2020, 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.
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version…
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and…
Potential Foreign Material
Stabilizer was made with Citric Acid instead of Sodium Citrate.
Stabilizer was made with Citric Acid instead of Sodium Citrate.
Undeclared Wheat and Milk.
Firm was notified by supplier of Elder Berries of a recall due to potential Salmonella contamination.
Processing error resulting in mixing of pasteurized and raw cider into final product.
GMP Deviations
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
GMP Deviations
Failed Dissolution Specifications: Out of specification for dissolution.
Labeling: Product Contains Undeclared API; Incorrect formulation
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
General Motors LLC (GM) is recalling certain 2021 Chevrolet Suburban and Tahoe and GMC Yukon and Yukon XL vehicles. During general assembly, a repair involved removal of one or both front…
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.