LYSO Disk — Class III medical device recall Z-0637-2022
Terminated recall by Microbiologics Inc, reported 2022-02-16. Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
| Recall number | Z-0637-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2017-03-02 |
| Classified | 2022-02-10 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2022-04-22 |
| Countries outside the US | CA, DE |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10845357022728 |
| Lot numbers | 939-47-1 |
| Model numbers | 0939L |
Product
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Reason for recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
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-0637-2022. 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.