Radiometer Medical ApS AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The recall — FDA Z-1394-2023
Due to potential software issue that may result in patient mix-up information.
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.
Due to potential software issue that may result in patient mix-up information.
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert…
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage.…
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Incorrect Unique Device Identifier/GTIN code was used on product.
Foreign material in product (fibrous contaminant)
Package contains "Bacon Glaze" resulting in: demerara sugar, honey granules, maple sugar, cinnamon, all spice, clove, parsley being undeclared on the label
Package actually contains "Coffee Chili Rub" resulting in sea salt, ancho chile, espresso beans, mustard, coriander, ginger, oregano, chipotle chile being undeclared on the label
A shard of glass being found in one of the jars.
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Kia America, Inc. (Kia) is recalling certain 2023 Sportage, Sportage Hybrid, Sportage Plug-in Hybrid, Niro Hybrid, Niro Plug-in Hybrid, Soul, and Telluride vehicles equipped with a digital…
Subaru of America, Inc. (Subaru) is recalling certain 2023 Impreza vehicles. The brake light switch may be improperly adjusted and illuminate the brake lights without application of the…
Ford Motor Company (Ford) is recalling certain 2023 Bronco and Ranger vehicles. The lug nuts on the driver's side wheels may have been improperly tightened.
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be…
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified…
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
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