Data Foundry

Medical device recalls 2025

KWIK-STIK and LYFO DISK — Class II medical device recall Z-2124-2025

Ongoing recall by Microbiologics Inc, reported 2025-07-23, distributed in OH, UT. Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may

Recall numberZ-2124-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2025-06-17
Classified2025-07-17
Reported by FDA2025-07-23
DistributedOH, UT
Countries outside the USAR, BD, ES, IT, JO, KR, NL
Quantity21 total
Pathogensstaphylococcus
UPC / GTIN / UDI-DI10845357019544, 30845357019531
Lot numbers805-234-4, 805-234-5
Model numbers0805K, 0805L

Product

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Reason for recall

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

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-2124-2025. 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.