Consumer Alerts TrackerIndependent U.S. recall decision aid
How it works Search recalls
Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 22, 2026

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Full official product description

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194. | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.; Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.; plus 2 additional official variants listed below.

Identifiers to compare

  • UDI 0082192500586
  • UDI 00821925001053
  • UDI 00821925003538
  • UDI 00821925001077
  • Model 194
  • Model 188
  • Model 190A
  • Model 188A
  • Lot s.
  • Lot Numbers

4 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.3,241 unitsZ-2720-2026
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.190 unitsZ-2718-2026
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.3,663 unitsZ-2721-2026
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers1,156 unitsZ-2719-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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 classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.