Recall Z-2194-2025— Microbiologics Inc

Name: FDA recall Z-2194-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-27

Class II · Ongoing

Class II FDA medical device recall by Microbiologics Inc, initiated 2025-06-27. It names one FDA 510(k) clearance: K861022. Product: LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack). Reason: 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..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-06-27
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

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

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.

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