Agency classClass IIOur severity:High FDA (Devices)·Z-0985-2021·Announced 2021-02-17

Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

Aomori Olympus is recalling SD-210U-15 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 is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile equipment, which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling the SD-210U-15 Electrosurgical Snare. This medical device is used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall affects 260,395 units distributed nationwide in the United States, with a global total of 7,400,000 units. Affected lots include codes 05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, and 9YV.

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 in this context may lead to patient infections.

Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for further instructions on returns or replacements. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns about potential infection risks.

The recalled product

Product: SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopic / Electrosurgical
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 (20)

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