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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2022%22
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