KWIK-STIK — Class II medical device recall Z-0582-2022
Terminated recall by Microbiologics Inc, reported 2022-02-16, distributed nationwide. Potential contamination with S. epidermidis E. coli and S. warneri.
| Recall number | Z-0582-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-10-01 |
| Classified | 2022-02-08 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2022-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, DE, FR, HK, ID, IE, IN, IT, JO, JP, LV, MX, NL, PE, PH, PL, RO, SA, VN, ZA |
| Quantity | 271 units |
| Reason classes | microbial contamination |
| Pathogens | e coli |
| UPC / GTIN / UDI-DI | 20845357022947, 30845357022951 |
| Lot numbers | 947-126-2, 947-126-3, 947-126-4 |
| Model numbers | 0947K, 0947P |
Product
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.
Reason for recall
Potential contamination with S. epidermidis E. coli and S. warneri.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0582-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.