FDA Device recall Z-2721-2026
Olympus Glass Body for 194 Ellik Evacuator
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Olympus Glass Body for 194 Ellik Evacuator by Olympus, citing some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2721-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-05 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Reason
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Identifiers
| code_info | Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2721-2026%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.