ClearanceBrief
Recall Z-0585-2026 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Remel, Inc

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

DateNov 21, 2025 (initiated Nov 12, 2025)
StatusOpen, Classified
ReasonProducts may contain contamination, which may result in a darker or brown media color.
Root causeUnder Investigation by firm
ActionOn November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.
Quantity1,000 US, 280 ROW
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K790687BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2
Gibco Laboratories Life Technologies, Inc., May 3, 1979
K802957MUELLER HINTON BROTH
Gibco Laboratories Life Technologies, Inc., Dec 22, 1980