Aomori Olympus Recalls Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling NA-401D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.
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 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 NA-401D-1521 aspiration needle, a medical device used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall involves 260,395 units in the United States and 7,400,000 units globally, distributed nationwide in the US.
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 stop using the affected devices and contact the recalling firm for instructions on return or replacement. The affected lot codes are 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recalled product
- Product
- NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- 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 (14)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
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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