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U.S. Department of Health and Human Services

Class 2 Device Recall CAMHB, Brucella Broth

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 Class 2 Device Recall CAMHB, Brucella Brothsee related information
Date Initiated by FirmNovember 12, 2025
Date PostedNovember 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0585-2026
Recall Event ID 97967
510(K)NumberK790687 K802957 
Product Classification Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
Product1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Code Information 1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactErica Knox
800-255-6730
Manufacturer Reason
for Recall		Products may contain contamination, which may result in a darker or brown media color.
FDA Determined
Cause 2		Under 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.
Quantity in Commerce1,000 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JTZ
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