1. Camhb W/Lhb, Manual, 11ml, 10/Box Ycp112-10 recallZ-0585-2026 · Remel, Inc · initiated Nov 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products may contain contamination, which may result in a darker or brown media color.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0585-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2025
- Posted by the FDA
- Nov 21, 2025
- Recalling firm
- Remel, Inc
- Quantity
- 1,000 US, 280 ROW
- Product code
- JTZ
- FDA submissions
- K790687, K802957
- 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 description
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Code information (models, lots, serial numbers)
1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NA CP112-10Remel, Inc. · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
- Sensititre Supplemental Brucella Broth T3450Remel, Inc. · Culture Media, General Nutrient Broth1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page