Data Foundry

Medical device recalls 2025

KWIK-STIK 2-Pack — Class II medical device recall Z-0984-2026

Ongoing recall by Microbiologics Inc, reported 2025-12-31, distributed nationwide. Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from AT

Recall numberZ-0984-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2025-12-02
Classified2025-12-22
Reported by FDA2025-12-31
DistributedNationwide (US)
Reason classesdevice malfunction
UPC / GTIN / UDI-DI20845357006459
Lot numbers325-120-3, 325-120-7
Model numbers0325P

Product

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Reason for recall

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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-0984-2026. 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.