Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Summary
The FDA issued a Class II for Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb by Olympus Corporation of the Americas. Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to.
Details
Source
Device Recall
External ID
Z-2720-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Lot/Code Info: Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
Quantity Affected: 3,241 units
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
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-05
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Olympus Corporation of the Americas has 339 FDA actions in our database, including 339 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 339 FDA actions in our database, including 339 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2720-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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