# FDA recall Z-0975-2021

> **Aomori Olympus Co., Ltd.** · Class II · device recall initiated 2021-01-04.

## Product

KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

## Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0975-2021
- **Recalling firm:** Aomori Olympus Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-04
- **Report date:** 2021-02-17
- **Termination date:** 2024-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kuroishi, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0975-2021

## Citation

> AI Analytics. FDA recall Z-0975-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0975-2021. Source: US FDA. Licensed CC0.

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