Data Foundry

Medical device recalls 2025

LYFO-DISK — Class II medical device recall Z-2195-2025

Ongoing recall by Microbiologics Inc, reported 2025-08-06, distributed nationwide. KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorga

Recall numberZ-2195-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2025-06-27
Classified2025-07-29
Reported by FDA2025-08-06
DistributedNationwide (US)
Countries outside the USBR, CO, CR, FI, FR, IN, JP, MY, PE, PH, PL, TR, TT, VN
UPC / GTIN / UDI-DI10845357021967
Lot numbers894-76-4, 894-76-6
Model numbers0894L

Product

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2195-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.