FDA: Device Recalls Class I

Trividia Health Class I Recall Z-1546-2026

The FDA has issued a Class I recall for Trividia Health's TRUE METRIX PRO Meter and Starter Kit due to inadequate labeling instructions for the E-5 error code. This recall impacts worldwide distribution, including the US, UK, Mexico, Jamaica, Trinidad & Tobago, and Australia.

Trividia Health Class I Recall Z-1547-2026

The FDA has issued a Class I recall for Trividia Health's TRUE METRIX AIR blood glucose measuring device kits due to labeling that did not adequately instruct users on how to address the E-5 error code. This recall affects worldwide distribution, including the US, UK, Mexico, Jamaica, Trinidad & Tobago, and Australia.

Trividia Health Class I Recall for Blood Glucose Devices

The FDA has issued a Class I recall for Trividia Health's blood glucose measuring devices due to inadequate labeling instructions for the E-5 error code. This recall affects owner's booklets and instructions for use distributed worldwide. Consumers and healthcare providers are advised to be aware of potential issues with device readings.

Trividia Health Class I Recall for Blood Glucose Devices

The FDA has issued a Class I recall for Trividia Health's blood glucose measuring devices due to inadequate labeling regarding the E-5 error code. This recall affects worldwide distribution, including the US, UK, Mexico, Jamaica, Trinidad & Tobago, and Australia. The issue could lead to serious adverse events.

Abiomed Impella RP Flex Class I Recall - Sensor Malfunction

The FDA has issued a Class I recall for Abiomed Impella RP Flex devices due to a potential malfunction of the differential pressure (dP) sensor. This malfunction can cause sensor values to drift, potentially impacting patient care. The recall affects devices distributed worldwide.

FDA Class I Recall: Abiomed Impella RP Sensor Malfunction

The FDA has issued a Class I recall for Abiomed Impella RP devices due to a sensor malfunction that can cause values to drift. This recall affects devices distributed worldwide, including nationwide in the US. The recall is ongoing.

Abiomed Impella RP Class I Recall - Sensor Malfunction

The FDA has classified a recall of Abiomed Impella RP devices as Class I due to a sensor malfunction. The differential pressure (dP) sensor may drift, potentially affecting device performance. The recall is ongoing and has worldwide distribution.

SunMed Broselow Tape Recall - Class I

The FDA has issued a Class I recall for SunMed Holdings' Broselow Pediatric Emergency Rainbow Tape due to potentially harmful dosing errors for specific medications. The recall affects worldwide distribution, including the US, Canada, Hong Kong, and Singapore.

Medline Class I Device Recall Z-1013-2026 for Beds

The FDA has classified a recall by Medline Industries, LP for their Full Electric Basic Homecare Beds as Class I, indicating a potential health hazard. The recall (Z-1013-2026) is ongoing and affects beds distributed in the US and other territories. The issue involves the hand control pendant and associated wires.

Abbott FreeStyle Libre 3 Sensor Recall - Incorrect Glucose Results

The FDA has issued a Class I recall for Abbott's FreeStyle Libre 3 Plus Sensor due to a manufacturing defect that may cause incorrect low glucose results. This recall impacts devices distributed across multiple U.S. states and requires immediate attention from healthcare providers and potentially patients.