Agency classClass IIOur severity:High FDA (Devices)·Z-1038-2021·Announced 2021-02-17

Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

Aomori Olympus is recalling NeedleMaster 6mm x 23G Upper needles because some sterile packages have inadequate seals, posing an 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 involves a risk-of-harm product (infection risk 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 NeedleMaster 6mm x 23G Upper (model no. NM-610L-0623). These medical devices are used with endoscopes to perform endoscopic vascular or submucosal injection in the gastrointestinal tract. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The products 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 due to these seal defects may cause patients to develop infections.

Healthcare providers and consumers should stop using the affected products immediately. The affected lot codes are 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 05V, 06V, 07V, 08V, 09V, and 0XV. Users should contact the manufacturer for further instructions on how to return or dispose of the recalled items.

The recalled product

Product: NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopic Injection Needle
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 (14)

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