Quick Facts at a Glance
- Recall Date
- October 30, 2025
- Hazard Level
- HIGH
- Brand
- Olympus
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT
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
- Product type
- Endoscopic ligating device
- Model numbers
- HX-400U-30, 04953170368615
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 30, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
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 HX-400U-30 is a single-use endoscopic ligating device that delivers a nylon loop snare during certain procedures. It is used in conjunction with an Olympus endoscope.
Why This Is Dangerous
If the ligation loop cannot release or detach, it may stay fixed around patient tissue or anatomy, potentially causing constriction or injury during a procedure.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to pause procedures involving HX-400U-30 until replacement devices or guidance are issued. The recall affects 7,803 units distributed nationwide.
Practical Guidance
How to identify if yours is affected
- Locate devices marked HX-400U-30
- Check lot status and expiration date
- Refer to recall letter for instructions
Where to find product info
Recall letters, FDA recall page, and Olympus official notices
What timeline to expect
Replacement or remediation timelines typically 4-8 weeks depending on recall logistics
If the manufacturer is unresponsive
- Document all communications
- File a complaint with CPSC if appropriate
- Seek guidance from hospital risk management and legal counsel
How to prevent similar issues
- Only purchase through authorized distributors
- Verify device model and recall status before use
- Maintain a recall compliance plan in clinical procurement
- Watch for updated recall notices from FDA and Olympus
Documentation advice
Keep recall letters, correspondences, receipts, photos of devices and packaging, and notes of any clinical decisions related to the recall
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model/Catalog Number: HX-400U-30 UDI: 04953170368615 All Lots which have not expired Quantity: 7803 units Distribution: US-wide distribution Sold at: Unknown When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model HX-400U-30
- All non-expired lots included
- Active recall as of 2025-12-03
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.