Agency classClass IIOur severity:High FDA (Devices)·Z-0972-2021·Announced 2021-02-17

Aomori Olympus Recalls K-203 Guide Sheath Kits Due to Seal Defects

Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

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 K-203 GUIDE SHEATH Kit 2.6MM (model no. K-203). This medical device is used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall covers 260,395 units in the United States, with a global total of 7,400,000 units. The affected products were distributed nationwide in the US.

The recall was initiated after inspections confirmed that a small percentage of the sterile packages had inadequate package seals, specifically partial heat seals. If non-sterile equipment is used due to these defects, patients may develop infections.

Healthcare providers and facilities should stop using the affected K-203 Guide Sheath Kits and contact Aomori Olympus Co., Ltd. for instructions on how to return or dispose of the products. The affected lot codes are 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK.

The recalled product

Product: K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopy Accessories
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 (17)

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