FDA Medical devices recall ·
LYFO DISK, Campylobacter jejuni subsp recall
- Recall number
- Z-0986-2026
- Date
- (initiated December 2, 2025)
- Company / brand
- Microbiologics Inc
200 Cooper Ave N, Saint Cloud, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit (16 additional units added 12/22/25)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Why was it recalled?
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
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: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6
Distribution
Worldwide - US Nationwide.
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-0986-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.