Integra LifeSciences Extended Tip Applicator, 8CM, Box of 5 recall — FDA Z-1958-2025
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
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Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Out of specification stability test result for the Caphosol B solution from process validation lots
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software…
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Undeclared wheat
Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.
The recall was the result of the firm's routine sampling program and Listeria monocytogenes was detected in an in-process shrimp sample in a food production environment.
Undeclared Milk.
The quantity of product in each unit does not match the stated weight.
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