FDA: Device Recalls Class II

Instrumentation Laboratory Class II Recall Z-1533-2026

The FDA has issued a Class II recall for Instrumentation Laboratory's GEM Premier 5000 device due to an increased incidence of 'Process Control Solution Not Detected' errors. The recall, initiated voluntarily by the firm, affects approximately 8 units distributed worldwide.

International Life Sciences Class II Device Recall

The FDA has reported a Class II device recall initiated voluntarily by International Life Sciences for their Artelon FlexBand Dynamic Matrix (Ref: 31057). The recall is ongoing due to augmentation devices failing bacterial endotoxin testing. The distribution was worldwide.

Beckman Coulter Class II Device Recall in Japan

The FDA is reporting on an ongoing Class II voluntary recall initiated by Beckman Coulter Mishima K.K. in Japan for their CHEMISTRY ANALYZER AU5800 due to a software issue that could delay patient diagnosis and treatment. The recall affects 47 units distributed nationwide in the US.

FDA Class II Recall of GEM Premier 5000 PAK

The FDA has classified a voluntary Class II recall initiated by Instrumentation Laboratory for their GEM Premier 5000 PAK (Part No. 00055360004). The recall is due to an increased incidence of Process Control Solution Not Detected (PCSND) errors, which can lead to GEM PAK ejection and potential operational disruptions. The recall affects 51 units distributed worldwide.

Waldemar Link GmbH Class II Device Recall

The FDA is reporting an ongoing Class II device recall initiated voluntarily by Waldemar Link GmbH & Co. KG for their Endo-Model Replacement Plateau. The recall affects 2 units distributed worldwide, including in the US, due to a potential for implant component detachment.