Z-2720-2026 Class II Ongoing
FDA device recall Z-2720-2026 was initiated by Olympus Corporation of the Americas on May 5, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 3,241 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- May 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,241 units
Product Description
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Code Information
Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.