RecallRadar

FDA Device recall Z-2225-2025

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

On 2025-08-06 the FDA classified a Class II recall of Blood/EMB, Levine 100/PK, Product Number R02041 by Remel, citing the products may contain surface and subsurface contamination of Listeria monocytogenes.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2225-2025
ClassificationClass II
Statusongoing
Initiated2025-07-11
Published2025-08-06
Last updated2026-09-13 11:57 UTC
CompanyRemel
DistributionUS

Product

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

Reason

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

Identifiers

code_infoUDI-DI: 848838003684; Lot Numbers: 274194

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2225-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.