FDA Device recall Z-1282-2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215 by Olympus, citing devices which did not undergo thermoforming could deform and lose performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1282-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-07 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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 current.
Reason
Devices which did not undergo thermoforming could deform and lose performance.
Identifiers
| code_info | Model/Catalog Number: KD-VC412Q-0215; Material REF: (1) N5391410, (2) N5391430, (3) N5777730; UDI-DI: (1) 0495317037115…Model/Catalog Number: KD-VC412Q-0215; Material REF: (1) N5391410, (2) N5391430, (3) N5777730; UDI-DI: (1) 04953170371158, (2) 04953170371158, (3) 04953170371158; All Lots with a valid expiration date |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2026%22
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