FDA Medical devices recall ·
Strep Selective II Agar, Product Number R01859 recall
- Recall number
- Z-2224-2025
- Date
- (initiated July 11, 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
- 371 units
- Hazard tags
- Listeria Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Strep Selective II Agar, Product Number R01859
Why was it recalled?
The products may contain surface and subsurface contamination of Listeria monocytogenes.
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
UDI-DI: 848838003158; Lot Numbers: 271613
Distribution
US Nationwide distribution.
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-2224-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.