FDA Class II Recall: Bisaf Strep A Self-Test

The FDA has initiated a Class II recall for the Bisaf Strep A Self-Test due to the product not being cleared by the FDA. This recall affects nationwide distribution within the US. The recall is ongoing.

Waldemar Link Class II Device Recall Z-1518-2026

The FDA has issued a Class II device recall (Z-1518-2026) for Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau, item number 15-8521/09. The recall is due to the potential for a plateau screw's bushing to detach from the screw shaft because of a longitudinal fracture. Distribution was worldwide, including the US state of NJ.

Wondfo Streptococcal A At-Home Self-Test Recall

The FDA has initiated a Class II recall for the Wondfo Streptococcal A At-Home Self-Test due to the product not being cleared by the FDA. The recall affects nationwide distribution within the US.

Boston Scientific EndoVive PEG Kit Class II Recall

The FDA has initiated a Class II recall for Boston Scientific's EndoVive Safety PEG Kit due to compromised sterile swabstick packaging. The recall affects nationwide distribution in the US and is ongoing. This action addresses potential loss of sterility or drying of the antiseptic solution.

GEM Premier 5000 PAK Recall - PCSND Errors

The FDA has issued a Class II recall for Instrumentation Laboratory's GEM Premier 5000 PAK (Part No. 00055407504) due to Process Control Solution Not Detected (PCSND) errors. The recall affects worldwide distribution, including the US.

Waldemar Link Class II Device Recall Z-1519-2026

The FDA has issued a Class II device recall (Z-1519-2026) for Waldemar Link's Endo-Model Replacement Plateau due to the potential for a plateau screw bushing to detach from the screw shaft. The recall impacts worldwide distribution, including the US state of NJ.

Waldemar Link Class II Recall: Bushing Detachment

The FDA has issued a Class II recall for Waldemar Link's Endo-Model Replacement Plateau (Item Number: 15-0027/12) due to the potential for bushing detachment from the screw shaft. This recall affects worldwide distribution, including nationwide distribution in the US.

Waldemar Link Endo-Model Plateau Device Recall Z-1523-2026

The FDA has issued a Class II recall for the Waldemar Link Endo-Model Replacement Plateau (Item Number: 15-0027/16) due to the potential for the bushing to detach from the screw shaft. The recall is ongoing and has seen worldwide distribution, including nationwide in New Jersey, US.

Olympus Biopsy Valve Recall - Rubber Fragment Detachment

The FDA has initiated a Class II recall for Olympus Single Use Biopsy Valves (Model MAJ-210) due to the potential for rubber fragments to detach during use. The recall impacts nationwide distribution in the US.

Olympus Biopsy Valve Recall Class II Z-1489-2026

Olympus Biopsy Valve Recall Class II Z-1489-2026