Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1279-2026.
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: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
- 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 (8)
- Model/Catalog Number: KD-VC411Q-0730
- Material REF: (1) N5391330
- (2) N5391310
- (3) N5777630
- UDI-DI: (1) 04953170399329
- (2) 04953170399329
- (3) 04953170399329
- All Lots with a valid expiration date
Distribution
Distributed nationwide across the United States.
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