Agency classClass IIOur severity:High FDA (Devices)·Z-0983-2021·Announced 2021-02-17

Aomori Olympus Recalls Electrosurgical Snare Due to Inadequate Package Seals

Aomori Olympus is recalling KD-655U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

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 injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling the KD-655U Electrosurgical Snare, model no. KD-655U. This medical device is used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. The recall involves 260,395 units distributed in the United States, with a global total of 7,400,000 units. Affected product codes include 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 sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.

Healthcare facilities and consumers should check their inventory for the KD-655U Electrosurgical Snare with the listed product codes. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement, in accordance with the recall instructions provided by Aomori Olympus Co., Ltd.

The recalled product

Product: KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - 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 — Endoscopy
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