Quick Facts at a Glance
- Recall Date
- November 11, 2025
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Product type
- Urological and Gynecological Sheath
- Model numbers
- Model No. WA22017A, UDI: 04042761051514, All Lots.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 11, 2025
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Complaints of the ceramic tip of the resection sheath breaking have been received.
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
About This Product
The Olympus Inner Sheath Model No. WA22017A is used in urological and gynecological procedures to facilitate various medical interventions. Healthcare professionals utilize these sheaths for their precision and reliability during surgeries.
Why This Is Dangerous
The ceramic tip of the resection sheath can break during medical use, potentially causing complications for patients. This defect poses a significant risk during critical procedures where device integrity is essential.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients who rely on this device for medical procedures. Immediate cessation of use is necessary to prevent potential injuries.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device.
- Verify the UDI number if available.
- Contact Olympus for confirmation if uncertain.
Where to find product info
Look for the model number on the device packaging or the product itself, typically located near the manufacturer's label.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after submission of the recall form.
If the manufacturer is unresponsive
- Document all correspondence with Olympus.
- Reach out to the FDA for further guidance.
- Consider consulting a legal professional if necessary.
How to prevent similar issues
- When purchasing medical devices, look for safety certifications and clear usage instructions.
- Stay updated on recalls from manufacturers and regulatory bodies.
- Consult with healthcare providers about alternative devices.
Documentation advice
Keep records of all communications regarding the recall, including emails, letters, and any receipts related to the product.
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Product Details
The recalled product is the Olympus Inner Sheath, Long, Model No. WA22017A. It is designed for urological and gynecological applications. The device was distributed nationwide in the U.S.
Key Facts
- Ceramic tip can break during use
- Risk of complications for patients
- Follow recall instructions immediately
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Safety Guide
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