FDA Device recall Z-0637-2022
LYSO Disk(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 LYSO Disk(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-0637-2022 |
| 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
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
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Identifiers
| code_info | Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Microbiologics
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.