Microbiologics KWIK-STIK Recalls: Potential Contamination with S. epidermidis E. coli
Microbiologics recalls KWIK-STIK products due to potential contamination with S. epidermidis, E. coli, and S. warneri. Affected units include 2-packs and 6-packs with specific catalog and lot numbers.
Recall notice
Potential contamination with S. epidermidis E. coli and S. warneri.
Contact the company
What happened, in plain English
Microbiologics is recalling KWIK-STIK products that may contain harmful bacteria like S. epidermidis, E. coli, and S. warneri. This could pose a health risk if the products are used improperly. Read more at govinfonow.com/recall/64128-microbiologics-kwik-stik-recalls-potential-contamination-with-s-epidermidis-e.
Source Summary by GovInfoNow · govinfonow.com/recall/64128-microbiologics-kwik-stik-recalls-potential-contamination-with-s-epidermidis-e · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0582-2022
Cite this page
“Microbiologics KWIK-STIK Recalls: Potential Contamination with S. epidermidis E. coli.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64128-microbiologics-kwik-stik-recalls-potential-contamination-with-s-epidermidis-e. Based on FDA recall #Z-0582-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2022%22&limit=1).
Why it’s dangerous
The products may contain harmful bacteria that could cause infections if used improperly. The specific bacteria mentioned (S. epidermidis, E. coli, and S. warneri) are known to cause infections in vulnerable individuals.
Who’s affected
Users of KWIK-STIK products, particularly those in medical settings or with compromised immune systems, are at risk if the products are contaminated.
How to tell if you have this one
Check for KWIK-STIK products with catalog numbers 0947P or 0947K. The affected units include 2-packs and 6-packs with specific lot numbers: 947-126-2, 947-126-4 for 0947P and 947-126-3 for 0947K.
- Brand
Microbiologics- Category
Medical device
All 3 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
Terminated- Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0582-2022 | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.; a. Catalog Number: 0947P; Lot Number: 947-126-2, 947-126-4; UDI: 20845357022947. b. Catalog Number: 0947K; Lot Number: 947-126-3; UDI: 30845357022951 | 271 units total |
| Z-0583-2022 | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements.; Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964 | 42 units |
| Z-0584-2022 | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.; Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718 | 11 units |
What to do — step by step
Check Product Details
Identify if your KWIK-STIK product has catalog numbers 0947P or 0947K and the listed lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0582-2022 (October 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0582-2022 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.