FDA Medical devices recall ·
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) recall
- Recall number
- Z-2195-2025
- Date
- (initiated June 27, 2025)
- Company / brand
- Microbiologics Inc
200 Cooper Ave N, Saint Cloud, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Why was it recalled?
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
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) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6
Distribution
Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
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-2195-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.