Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1285-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Devices which did not undergo thermoforming could deform and lose performance.
The recalled product
- Product
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model/Catalog Number: KD-411Q-0720
- Material REF: 5858030
- UDI-DI: Under Review
- All Lots with a valid expiration date
Distribution
Distributed nationwide across the United States.
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