KWIK-STIK — Class III medical device recall Z-0636-2022
Terminated recall by Microbiologics Inc, reported 2022-02-16. Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
| Recall number | Z-0636-2022 |
|---|---|
| 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 | 2 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20845357022701 |
| Lot numbers | 939-47-2 |
| Model numbers | 0939P |
Product
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
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-0636-2022. 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.