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Recall Observatory FDA recall evidence

Device product

Strep Selective II Agar, Product Number R01859

Z-2224-2025

July 11, 2025

Class II

Product summary

Firm
Remel, Inc
Event
Event 97224
Status
Ongoing
Classification
Class II
Quantity
371 units
Official record key
device-enforcement:Z-2224-2025

Official wording

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

Code information: UDI-DI: 848838003158; Lot Numbers: 271613

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination of Listeria monocytogenes