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
- 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
- Endoscopic Sheath
- Model numbers
- Model No. A37004A, UDI: 04042761023092, All Lots.
- Sold at
- Multiple Retailers
- 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 Sheath, Model No. A37004A, is used for endoscopic diagnosis and treatment in urological procedures. It is essential for medical professionals performing such procedures.
Why This Is Dangerous
The ceramic tip of the sheath can break, which may cause complications during endoscopic procedures. This defect poses a danger to patients and requires immediate attention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act promptly to avoid potential injuries related to this device. The recall creates an urgent need for safe alternatives in medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to see if it is A37004A.
- Ensure that you have not used the sheath in any procedures since receiving the recall notice.
- If in doubt, consult your healthcare provider.
Where to find product info
The model number and UDI can typically be found printed on the packaging or the device itself.
What timeline to expect
Expect a response from Olympus within 4-6 weeks regarding refunds or replacements.
If the manufacturer is unresponsive
- Document all communications with Olympus.
- Reach out to the FDA for assistance in filing a complaint.
- Consult a legal representative if you experience any injury.
How to prevent similar issues
- Look for FDA-approved devices in the future.
- Check for any recalls before purchasing medical supplies.
- Consult with healthcare professionals about device safety before use.
Documentation advice
Keep records of your product details, recall notices, and any correspondence with the manufacturer.
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Product Details
The affected product is the Olympus Sheath, model number A37004A, with UDI 04042761023092. The sheath is designed for endoscopic diagnosis and treatment in urological applications and was distributed nationwide in the U.S.
Key Facts
- Model No. A37004A
- Ceramic tip may break during use
- Stop using immediately
- Contact Olympus for instructions
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Safety Guide
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