Z-0585-2026Class II

1. Camhb W/lhb, Manual, 11Ml, 10/Box Ycp112-10 2. Brucella Broth, 11Ml, 10/Box Yt3450

Name: Z-0585-2026 1. Camhb W/lhb, Manual, 11Ml, 10/Box Ycp112-10 2. Brucella Broth, 11Ml, 10/Box Yt3450
Creator: Remel, Inc
Published: 2025-11-12
License: https://open.fda.gov/license/

Remel Inc / initiated 2025-11-12 / Open, Classified

FDA source

Remel, Inc began a recall of 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 on 2025-11-12. FDA classified it as Class II and gives the reason as "Products may contain contamination, which may result in a darker or brown media color". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0585-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-12
Posted: 2025-11-21
Recalling firm: Remel Inc
Product: 1. Camhb W/lhb, Manual, 11Ml, 10/Box Ycp112-10 2. Brucella Broth, 11Ml, 10/Box Yt3450
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: Products may contain contamination, which may result in a darker or brown media color.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1,000 US, 280 ROW
Distribution: 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.
Product codes and lots: 1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0585-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0585-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

Product code JTZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)