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.
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 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.
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)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
- 05V
- 06V
- 07V
- 08V
- 09V
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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