Quick Facts at a Glance
- Recall Date
- May 5, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Model numbers
- Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 5, 2026
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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Full Description
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.. Reason: 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.. Classification: Class II. Quantity: 3,663 units. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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