Agency classClass IIOur severity:High FDA (Devices)·Z-0994-2021·Announced 2021-02-17

Aomori Olympus ForceMax Injector Recall Due to Package Seal Defects

Aomori Olympus is recalling ForceMax injectors 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 involves a risk-of-harm product (infection risk from non-sterile equipment) where no specific injuries or illnesses have been reported yet, fitting the criteria for a High severity score.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling the INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM (model no. NM-400L-0423). These medical devices are used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive 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 presents a risk that patients may develop infections.

Approximately 260,395 units were distributed in the United States, with a total of 7,400,000 units distributed globally. The affected units were distributed nationwide in the US. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product: INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Endoscopic Injector
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 (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