Agency classClass IIOur severity:High FDA (Devices)·Z-1040-2021·Announced 2021-02-17

Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects

Aomori Olympus is recalling 260,395 NeedleMaster needles in the US 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 3MMx 23G LOWER (model no. NM-610U-0323) endoscopic injection needles. This recall affects 260,395 units distributed nationwide in the United States. The product is used with endoscopes to perform endoscopic vascular or submucosal injection in the gastrointestinal tract.

The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.

Healthcare providers and facilities should check their inventory for the affected model number and lot codes (01K through 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V through 09V, and 0XV). Affected units should be removed from use and returned to the manufacturer or authorized distributor for credit or replacement.

The recalled product

Product: NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - 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 Needles
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