Agency classClass IIOur severity:High FDA (Devices)·Z-0974-2021·Announced 2021-02-17

Aomori Olympus Recalls KD-611L Electrosurgical Knives Due to Seal Defects

Aomori Olympus is recalling KD-611L electrosurgical knives 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 is classified as FDA Class II. The hazard involves a risk of infection from non-sterile equipment, which is a significant health risk, but the source text does not report any specific hospitalizations or injuries, placing it in the 'High' category rather than 'Severe'.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling the KD-611L Electrosurgical Knife, model no. KD-611L. 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 in the United States, with a global total of 7,400,000 units. The affected units were distributed nationwide in the US.

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 providers and consumers should check their inventory for the KD-611L Electrosurgical Knife with lot codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, or 9ZK. Affected units should be removed from service and returned to the manufacturer or authorized distributor for replacement or refund.

The recalled product

Product: KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - 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 Instruments
Hazard: infection
sterility-failure

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