Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Failed Dissolution Specifications
Failed Dissolution Specifications
Fujifilm is reporting a corrective action due to an FDA inspection.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
Some anomalies have been identified during manufacturing controls.
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal…
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message…
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in…
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Software discrepancy of not showing all the EE constants, when the screen is filled.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Presence of loose polypropylene foreign matter above release specification.
Software discrepancy of not showing all the EE constants, when the screen is filled.
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Browse recent months with enough recall history for useful comparison.
