Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor
Summary
The FDA issued a Class II for Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. by Olympus Corporation of the Americas. Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Inst.
Details
Source
Device Recall
External ID
Z-2146-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Lot/Code Info: Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers
Quantity Affected: 2 units
Reason for Recall
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Distribution
International distribution to the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-18
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 122 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 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 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2146-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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