Agency classClass IIOur severity:High FDA (Devices)·Z-1070-2021·Announced 2021-02-17

Aomori Olympus Recalls Crescent Snare Due to Inadequate Package Seals

Aomori Olympus Co., Ltd. is recalling Crescent Snare models due to inadequate package seals that may compromise sterility and increase 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 is classified as FDA Class II and 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 CRESCENT SNARE, model no. SD-221L-25, a medical device used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall involves 260,395 units distributed in the United States and 7,400,000 units globally.

Inspection confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. If non-sterile equipment is used, patients may develop infections.

The recall is classified as Class II by the FDA. Healthcare providers and consumers should check their inventory for the affected lot codes (01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK) and stop using the product if the seal is compromised.

The recalled product

Product: CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopic Instruments
Hazard: infection
sterility-compromise

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 (18)

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 →

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Same hazard · infection