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.
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the…
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup…
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
eCareManager (eCM) Sentry Score software not approved for use
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of…
A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the…
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Certain lots may not have been packaged wth the Channel Tube Limiter.
Under pasteurization. Cheese product was made from one batch of milk that was under pasteurized.
Product that did not meet quality standards was released in error. Complaints of spoilage received.
The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.
Product may contain a foreign object (glass).
The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.
The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.
Under pasteurization. Cheese product was made from one batch of milk that was under pasteurized.
cGMP deviations
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
cGMP deviations
Browse recent months with enough recall history for useful comparison.
