CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

Olympus Toomey Evacuator 30cc with Adaptor recalled

Olympus Corporation of the Americas is recalling Olympus Toomey Evacuator 30cc with Adaptor, distributed nationwide in the US. The recall was initiated on 5 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 188. UDI-DI: 00821925001053. All Lot Numbers.

Quantity recalled190 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2718-2026
FDA event ID: 98869
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 5 May 2026
FDA classified: 10 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

5 May 2026	Recall initiated by company
10 Jul 2026	Classified by FDA	+66 days
22 Jul 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 98869

This product is part of a recall event; the main page for the event is Olympus Ellik Evacuator Includes Glass Body recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026	CLASS II	Olympus Ellik Evacuator Includes Glass Body recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide

More recalls from Olympus Corporation of the Americas

All 415

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2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
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29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

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