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Lower risk Medical device recall · FDA · Published June 27, 2025

Microbiologics LYFO-DISK Recall: Risk of Failed Microorganism Recovery

Microbiologics recalls LYFO-DISK products with REF 0894K and 0894P packaging due to risk of failing to recover target microorganisms. Affected lots include 894-76 series.

🇺🇸 FDA recall #Z-2194-2025Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling LYFO-DISK products (REF 0894K and 0894P) because they may fail to recover the target microorganism. This could affect lab users who rely on these products for microbiological testing. Read more at govinfonow.com/recall/51953-microbiologics-lyfo-disk-recall-risk-of-failed-microorganism-recovery.

Source Summary by GovInfoNow · govinfonow.com/recall/51953-microbiologics-lyfo-disk-recall-risk-of-failed-microorganism-recovery · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2194-2025

Cite this page

“Microbiologics LYFO-DISK Recall: Risk of Failed Microorganism Recovery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51953-microbiologics-lyfo-disk-recall-risk-of-failed-microorganism-recovery. Based on FDA recall #Z-2194-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2194-2025%22&limit=1).

The FDA announced on June 27, 2025, that Microbiologics Inc is recalling LYFO-DISK and KWIK-STIK products due to the risk of failing to recover target microorganisms. The agency issued recall number Z-2194-2025 for the voluntary Class II action.

How to tell if you have it

  • Brand: Microbiologics
  • Product: LYFO-DISK, M. Canis Derived from ATCC 36299
  • REF 0894K (6-pack), UDI/DI 30845357021954, Lot Numbers: 894-76-81
  • REF 0894P (2-pack), UDI/DI 20845357021940, Lot Numbers: 894-76-21, 894-76-51, 894-76-52
  • KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK 0894L
  • All lots of REF 894-76
  • Units affected: 32

The hazard

The recalled items may result in failure to recover the target microorganism. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls of similar products include Microbiologics KWIK-STIK 6-Pack Recall (December 2, 2025), Microbiologics KWIK-STIK Quality Control Kit Recall (November 13, 2025), and Microbiologics KWIK-STIK and LYFO DISK recall (June 17, 2025). Other recent recalls of similar products include Vivoo Protein Test Recall (November 22, 2025), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026), and Vivoo pH Test Recall (November 22, 2025).

How to tell if you have this one

Check for packaging labels with REF 0894K (6-pack) or REF 0894P (2-pack). Affected lots include 894-76-81, 894-76-21, 894-76-51, and 894-76-52.

  • Brand
    Microbiologics
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
Recall numberProduct, codes & lotsQuantity
Z-2194-2025LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack); 1) 0894K: UDI/DI 30845357021954, Lot Numbers: 894-76-81; 2) 0894P: UDI/DI 20845357021940, Lot Numbers: 894-76-21, 894-76-51, 894-76-52.32 units
Z-2195-2025LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L; 1) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Labels

    Look for REF 0894K (6-pack) or REF 0894P (2-pack) on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Jun 27, 202512. FDA classified it Class II: Jul 29, 202523. Published in FDA’s Enforcement Report: Aug 6, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2194-2025 (June 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2194-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA