LYFO DISK — Class II medical device recall Z-0583-2022
Terminated recall by Microbiologics Inc, reported 2022-02-16, distributed nationwide. Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
| Recall number | Z-0583-2022 |
|---|---|
| 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 | 42 units |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 10845357022964 |
| Lot numbers | 947-126-1 |
| Model numbers | 0947L |
Product
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.
Reason for recall
Potential contamination with Escherichia coli, Staphylococcus epidermidis 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-0583-2022. 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.