Agency classClass IIOur severity:High FDA (Devices)·Z-0981-2021·Announced 2021-02-17

Aomori Olympus Recalls KD-650U Electrosurgical Snare Due to Seal Defects

Aomori Olympus Co., Ltd. is recalling KD-650U Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (infection from non-sterile equipment) where no specific injuries or illnesses have been reported yet, fitting the criteria for a High severity score.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling the KD-650U Electrosurgical Snare, model no. KD-650U. This medical device is used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. The recall covers 260,395 units distributed in the United States, with a global total of 7,400,000 units. The affected units are identified by the following lot codes: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.

The recall was initiated after inspections confirmed that a small percentage of the sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment in this context may lead to patient infections.

Healthcare facilities and consumers should stop using the affected KD-650U Electrosurgical Snare units immediately. Users should check their inventory for the specific lot codes listed above and contact the recalling firm for instructions on how to return or dispose of the products.

The recalled product

Product: KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopic / Surgical
Hazard: infection
packaging-defect

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 (15)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 111 recalled by Aomori Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 111 products in this recall →

Same manufacturer · Aomori Olympus Co., Ltd.

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Same hazard · infection