FDA Medical devices recall ·
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2… recall
- Recall number
- Z-0585-2026
- Date
- (initiated November 12, 2025)
- Company / brand
- Remel, Inc
12076 Santa Fe Trail Dr, Lenexa, KS, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,000 US, 280 ROW
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Why was it recalled?
Products may contain contamination, which may result in a darker or brown media color.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287
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.
States: Alaska California Florida Georgia Iowa Illinois Indiana Louisiana Massachusetts Maryland Maine Michigan Minnesota Nebraska New York Ohio Oklahoma Pennsylvania Rhode Island South Dakota Tennessee Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0585-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.