Data Foundry

Medical device recalls 2025

remel BLOOD AGAR MacCONKEY AGAR BIPLATE — Class II medical device recall Z-1200-2025

Ongoing recall by Remel, Inc, reported 2025-02-26, distributed nationwide. Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible

Recall numberZ-1200-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemel, Inc, Lenexa, KS, United States
Recall initiated2025-02-13
Classified2025-02-20
Reported by FDA2025-02-26
DistributedNationwide (US)
Quantity787 units
Reason classesmicrobial contamination
Pathogenslisteria monocytogenes
UPC / GTIN / UDI-DI00848838003691
Lot numbers213926
Model numbers100, R02049
Expiration dates2025-02-24

Product

remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

Reason for recall

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

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-1200-2025. 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.