FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Published: February 11, 2026Recall ID: Z-1281-2026Category: devicesCountry: US
Reason for Recall / Hazard
Devices which did not undergo thermoforming could deform and lose performance.
Product Description & Identification
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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.
Affected Products
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98252 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model/Catalog Number: KD-VC411Q-0330; Material REF: (1) N5391130, (2) N5391110, (3) N5777430; UDI-DI: (1) 04953170371097, (2) 04953170371097, (3) 04953170371097; All Lots with a valid expiration date |
| Postal code | 18034-8229 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 5089 units (30 US, 5059 OUS) |
| Reason for recall | Devices which did not undergo thermoforming could deform and lose performance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260205 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.