Recall Z-2225-2025— Remel, Inc

Name: FDA recall Z-2225-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Blood/EMB, Levine 100/PK, Product Number R02041. Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-07-11
Firm location: Lenexa, KS, United States

Product description

Blood/EMB, Levine 100/PK, Product Number R02041

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.