DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0538-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Complete FDA and NHTSA recall records dated in February 2022.
These records include useful source details for the selected month.
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
BMW of North America, LLC (BMW) is recalling certain 2022 330i, 530i, X3 xDrive30i, and X4 xDrive30i vehicles. The mechatronics unit inside the transmission may not have been assembled…
Volkswagen Group of America, Inc. (Audi) is recalling certain 2022 Audi Q3 vehicles that failed to receive the software update under Recall 21V-825 (91CR). A software error may prevent the…
Tesla, Inc. (Tesla) is recalling certain 2020-2022 Model S, Model X, Model Y, and 2017-2022 Model 3 vehicles. The Boombox function allows sounds to be played through an external speaker…
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.