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Open, Classified

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

FDA Recall Z-0585-2026 · Posted 2025-11-21

Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeJTZ
Date Initiated2025-11-12
Product Quantity1,000 US, 280 ROW

Reason for Recall

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

Firm Action

On 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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K802957MUELLER HINTON BROTHGibco Laboratories Life Technologies, Inc. · 1980-12-22K790687BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2Gibco Laboratories Life Technologies, Inc. · 1979-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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