Class II

Medical Device Recall: Blood/EMB, Levine 100/PK, Product Number R02041

Remel, Inc · July 11, 2025

Reason for Recall

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

750 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2225-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.