Aomori Olympus Recalls MAJ-244 Replacement Baskets Due to Seal Defects
Aomori Olympus is recalling MAJ-244 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.
What this means for you
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 MAJ-244 Single Use 30mm Replacement Basket, model no. MAJ-244, which is used with the BML-3Q Mechanical Lithotripter. The recall involves 260,395 units in the United States and 7,400,000 units globally. The affected products were distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile medical equipment can lead to patient infections.
Healthcare providers and facilities should stop using the affected MAJ-244 replacement baskets and contact Aomori Olympus Co., Ltd. for instructions on how to return or dispose of the products. The affected lot codes are 01K, 02K, 04K, 05K, 06K, 07K, 09K, 92K, 93K, 94K, 95K, 97K, and 9XK.
The recalled product
- Product
- MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
- Manufacturer
- Aomori Olympus Co., Ltd.
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 (13)
- 01K
- 02K
- 04K
- 05K
- 06K
- 07K
- 09K
- 92K
- 93K
- 94K
- 95K
- 97K
- 9XK
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.
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