Recall Z-0985-2026— Microbiologics Inc

Name: FDA recall Z-0985-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-02

Class II · Ongoing

Class II FDA medical device recall by Microbiologics Inc, initiated 2025-12-02. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K. Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-02
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.