CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Olympus Toomey Evacuator 50cc with Adaptor recalled
Olympus Corporation of the Americas is recalling Olympus Toomey Evacuator 50cc 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
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-2719-2026
- 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 50cc with Adaptor. Model Number: 188A.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
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: 188A. UDI-DI: 00821925001077. 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 98869This 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 |
|---|---|---|---|---|---|
| CLASS II | Olympus Ellik Evacuator Includes Glass Body recalled | Olympus Corporation of the Americas | Sterility | Nationwide | |
| CLASS II | Olympus Toomey Evacuator 30cc with Adaptor recalled | Olympus Corporation of the Americas | Sterility | Nationwide | |
| CLASS II | Olympus Glass Body for 194 Ellik Evacuator recalled | Olympus Corporation of the Americas | Sterility | Nationwide |
More recalls from Olympus Corporation of the Americas
All 423| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus M3 Gold Autoclavable Lateral Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |