Agency classClass IIOur severity:High FDA (Devices)·Z-1068-2021·Announced 2021-02-17

Aomori Olympus Recalls MAJ-247 Replacement Baskets Due to Seal Defects

Aomori Olympus is recalling MAJ-247 replacement baskets for the BML-3Q Mechanical Lithotripter 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 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 MAJ-247 Single Use 30mm Replacement Baskets used with the BML-3Q Mechanical Lithotripter. The recall affects 260,395 units distributed in the United States, with 7,400,000 units affected globally. The 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. The use of non-sterile medical equipment can lead to patient infections.

Healthcare providers and consumers should stop using these specific replacement baskets immediately. Affected lot codes include 01K, 02K, 03K, 92K, 93K, 94K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK. Users should contact the manufacturer or their supplier for instructions on returning the affected units.

The recalled product

Product: MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Manufacturer: Aomori Olympus Co., Ltd.
Category: Medical Device — Surgical Instruments
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 (12)

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