Z-0585-2026 Class II Ongoing
FDA device recall Z-0585-2026 was initiated by Remel, Inc on November 12, 2025 and is designated Class II. Reason for recall: Products may contain contamination, which may result in a darker or brown media color. The recall status is ongoing. Affected quantity: 1,000 US, 280 ROW.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- November 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000 US, 280 ROW
Product Description
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Reason for Recall
Products may contain contamination, which may result in a darker or brown media color.
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.
Code Information
1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287