# FDA recall Z-1275-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-01-07.

## Product

Product Name: Single Use 3-Lumen Sphincterotome V  Model/Catalog Number:  KD-V431M-0720;  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 for recall

Devices which did not undergo thermoforming could deform and lose performance.

## Distribution

Worldwide - 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.

## Key facts

- **Recall number:** Z-1275-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2026

## Citation

> AI Analytics. FDA recall Z-1275-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1275-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*