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.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Subpotent Drug
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Potential for leak test failures.
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified…
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
The 30 minute maximum tanning time has been reduced to 20 minutes.
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The…
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap…
Potential for cracked luer hubs
Browse recent months with enough recall history for useful comparison.
