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Recall Observatory FDA recall evidence

Device product

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

Z-0585-2026

November 12, 2025

Class II

Product summary

Firm
Remel, Inc
Event
Event 97967
Status
Ongoing
Classification
Class II
Quantity
1,000 US, 280 ROW
Official record key
device-enforcement:Z-0585-2026

Official wording

Reason: Products may contain contamination, which may result in a darker or brown media color.

Code information: 1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products may contain contamination, which may result in a darker or brown media color.