FDA: Device Recalls Class I

Abiomed Class I Device Recall Z-1470-2026

The FDA has announced a Class I device recall for Abiomed's Impella RP Flex with SmartAssist due to a malfunctioning differential pressure (dP) sensor. This recall impacts approximately 4,496 units distributed worldwide and is ongoing.

Trividia Health Class I Device Recall Z-1545-2026

The FDA has classified a recall by Trividia Health, Inc. for certain blood glucose measuring device owner's booklets and instructions for use as Class I. The recall, designated Z-1545-2026, is ongoing and affects approximately 12 million units distributed worldwide.

Trividia Health Class I Device Recall

The FDA has issued a Class I device recall for Trividia Health's owner booklets and instructions for use associated with various TRUE METRIX GO blood glucose measuring devices. The recall is due to inadequate labeling regarding the E-5 error code, which could lead to delayed treatment for users experiencing high blood glucose levels.

Trividia Health Class I Device Recall

The FDA has initiated a Class I device recall for Trividia Health's blood glucose measuring devices due to inadequate labeling regarding error code E-5. This recall impacts approximately 3.6 million units distributed globally. The issue could lead to delayed treatment for high blood glucose levels.

Trividia Health Class I Device Recall

The FDA has announced a Class I device recall for Trividia Health's TRUE METRIX PRO blood glucose meters and associated owner's booklets/instructions for use. The recall is due to labeling that may not adequately direct users on how to respond to an E-5 error code, potentially delaying treatment for high blood glucose levels.