Data Foundry

Medical device recalls 2025

Strep Selective II Agar — Class II medical device recall Z-2224-2025

Ongoing recall by Remel, Inc, reported 2025-08-06, distributed nationwide. The products may contain surface and subsurface contamination of Listeria monocytogenes.

Recall numberZ-2224-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemel, Inc, Lenexa, KS, United States
Recall initiated2025-07-11
Classified2025-07-31
Reported by FDA2025-08-06
DistributedNationwide (US)
Quantity371 units
Reason classesmicrobial contamination
Pathogenslisteria monocytogenes
UPC / GTIN / UDI-DI00848838003158
Lot numbers271613

Product

Strep Selective II Agar, Product Number R01859

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2224-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.