Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb
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.
- Agency
- FDA Device
- Recall date
- May 5, 2026
- Status
- Ongoing
- Company
- Olympus Corporation of the Americas
1. What product was recalled?
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Quantity: 3,241 units
Code or lot text: Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
- LOT
- Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
- RECALL-NUMBER
- Z-2720-2026
Olympus Glass Body for 194 Ellik Evacuator
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Quantity: 3,663 units
Code or lot text: Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
- LOT
- Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
- RECALL-NUMBER
- Z-2721-2026
Olympus Toomey Evacuator 30cc with Adaptor
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Quantity: 190 units
Code or lot text: Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
- LOT
- Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
- RECALL-NUMBER
- Z-2718-2026
Olympus Toomey Evacuator 50cc with Adaptor
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Quantity: 1,156 units
Code or lot text: Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
- LOT
- Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
- RECALL-NUMBER
- Z-2719-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.