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Lower risk Medical device recall · FDA · Published December 16, 2020

Microbiologics KWIK-STIK and LYFO DISK Recall: Contamination Risk

Microbiologics recalls KWIK-STIK 2-Packs, 6-Packs, and LYFO DISK due to contamination with S. epidermidis. Affected items have specific catalog numbers and expiration dates.

🇺🇸 FDA recall #Z-0511-2022Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling KWIK-STIK 2-Packs, 6-Packs, and LYFO DISK products that may be contaminated with S. epidermidis. This contamination could pose a health risk if the products are used improperly. Read more at govinfonow.com/recall/63653-microbiologics-kwik-stik-and-lyfo-disk-recall-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63653-microbiologics-kwik-stik-and-lyfo-disk-recall-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0511-2022

Cite this page

“Microbiologics KWIK-STIK and LYFO DISK Recall: Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63653-microbiologics-kwik-stik-and-lyfo-disk-recall-contamination-risk. Based on FDA recall #Z-0511-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0511-2022%22&limit=1).

The FDA announced on Dec. 16, 2020, that Microbiologics Inc voluntarily recalled specific KWIK-STIK and LYFO DISK microbiological control products due to contamination with Staphylococcus epidermidis. The agency issued recall number Z-0511-2022 for the Class II violation.

How to tell if you have it

  • KWIK-STIK 2 Pack, Catalog #0894P
  • KWIK-STIK 6 Pack, Catalog #0894K
  • LYFO DISK, Catalog #0894L
  • Lot #: 894-68-3, Exp. 6/30/2022, UDI: 20845357022947
  • Lot #: 894-68-4, Exp. 6/30/2022
  • Lot #: 894-68-1, Exp. 6/30/2022, UDI: 30845357022951
  • Lot #: 894-68-2, Exp. 6/30/2022, UDI: 10845357022964

The hazard

The recalled Microsporum canis derived from ATCC 36299 was contaminated with S. epidermidis. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since 2017-06-06. Other recent recalls of similar products include Medline Convenience Kits Recall: Fungal Contamination Risk (2026-08-11), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (2026-06-12), and Hologic ThinPrep CytoLyt Solution Recall: Fungal Contamination Risk (2025-12-12).

How to tell if you have this one

Check for the catalog numbers: 0894P, 0894K, or 0894L. The products were sold with specific lot numbers and expiration dates listed in the recall notice.

  • Brand
    Microbiologics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the catalog number and expiration date on the product label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 13 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: yesSDIowa: yesIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Illinois, Iowa, Louisiana, Massachusetts, Michigan, New York, Pennsylvania, South Dakota, Tennessee, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Dec 16, 202012. FDA classified it Class II: Jan 19, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Jul 7, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0511-2022 (December 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0511-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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