FDA Device recall Z-0636-2022
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus
- FDA Device
- Class III
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class III recall of KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus by Microbiologics, citing potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0636-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-02 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | n/a |
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
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Identifiers
| code_info | Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2022%22
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