Quick Facts at a Glance
- Recall Date
- September 13, 2024
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Cystoscope Outer Sheath
- Model numbers
- Model: WA2280A, UDI: 04042761051729, Lot#: All lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 13, 2024
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
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 Cystoscope Outer Sheath is a medical device used during procedures for benign prostatic hyperplasia (BPH) therapy. Healthcare providers purchase this product to aid in patient treatments effectively.
Why This Is Dangerous
The device's incompatibility with the GreenLight Laser can lead to damage at the tip, affecting its functionality during medical use. This can potentially endanger patient safety during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this device may experience delays in treatment due to the recall. Immediate action is necessary to prevent possible complications during medical procedures.
Practical Guidance
How to identify if yours is affected
- Verify the model number on the device. It should read WA22810A.
- Check for any notification letters from Olympus Corporation regarding the recall.
- Consult with your healthcare provider to confirm if your device is affected.
Where to find product info
The model number can typically be found on the packaging or the device itself, usually near the handle or base.
What timeline to expect
Expect processing for refunds or replacements to take about 4-6 weeks after submission.
If the manufacturer is unresponsive
- Document your communications with Olympus Corporation.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if you receive no response.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Consult with healthcare providers about device compatibility.
- Ensure the device has proper safety certifications.
Documentation advice
Keep all correspondence related to the recall. Document any issues encountered with the device for future reference.
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Product Details
The recalled product is the Olympus Cystoscope Outer Sheath, Model WA22810A. All lots of this model are affected. The device was distributed nationwide in the United States.
Key Facts
- Recall date: September 13, 2024
- Model: WA22810A
- Quantity recalled: 633 units
- Distribution: Nationwide in the United States
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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