Class II Device Recall Z-1554-2026 for Artelon FlexBand

The FDA has initiated a Class II device recall (Z-1554-2026) for Artelon FlexBand Dynamic Matrix due to failed bacterial endotoxin testing. The recall affects worldwide distribution, including nationwide distribution within the US.

FDA Class II Device Recall: GEM Premier 5000

The FDA has issued an ongoing Class II device recall for Instrumentation Laboratory's GEM Premier 5000 due to customer complaints of Process Control Solution Not Detected (PCSND) errors. This recall affects worldwide distribution, including the US.

Waldemar Link Class II Device Recall Z-1517-2026

The FDA has issued a Class II device recall (Z-1517-2026) for Waldemar Link's Endo-Model Replacement Plateau due to the potential for implant bushing detachment. The recall affects worldwide distribution, including nationwide distribution in the US.

Waldemar Link Class II Device Recall Z-1511-2026

The FDA has issued a Class II device recall (Z-1511-2026) for Waldemar Link's Endo-Model SL Connection Component due to the potential for a plateau screw's bushing to detach. The recall is ongoing and has seen worldwide distribution, including nationwide in the US.

FDA Class II Device Recall - Raz-AT Mobile Shower Commode Chair

The FDA has issued a Class II device recall for Raz Design Inc.'s Raz-AT (Attendant Tilt) and Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chairs. The recall is due to a vendor modification that may lead to improper seat bracket engagement, posing a risk to users. Distribution was nationwide across multiple states.

GEM Premier 5000 Class II Device Recall Z-1539-2026

The FDA has issued a Class II device recall (Z-1539-2026) for the GEM Premier 5000, Model No. 00055430010, due to an increased incidence of 'Process Control Solution Not Detected' errors. This recall affects worldwide distribution, including the US.

GEM Premier 5000 Device Recall - PCSND Errors

The FDA has issued a Class II recall for the GEM Premier 5000 device due to an increased incidence of Process Control Solution Not Detected (PCSND) errors. This recall affects worldwide distribution, including the United States.

Waldemar Link Class II Device Recall Z-1520-2026

The FDA has issued a Class II device recall (Z-1520-2026) for Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau due to the potential for a plateau screw bushing to detach from the screw shaft. The recall affects worldwide distribution, including nationwide distribution in New Jersey and several countries.

FDA Class II Device Recall: GEM Premier 5000

The FDA has initiated a Class II device recall for Instrumentation Laboratory's GEM Premier 5000, Part No. 00055415008, due to Process Control Solution Not Detected (PCSND) errors. The recall affects worldwide distribution, including the US.

FDA Class II Device Recall: GEM Premier 5000 PAK

The FDA has initiated a Class II device recall for Instrumentation Laboratory's GEM Premier 5000 PAK (Part No. 00055407511) due to Process Control Solution Not Detected (PCSND) errors. The recall affects worldwide distribution, including the US.