Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
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 NEEDLEMASTER 4MMx 25G LOWER (model no. NM-610U-0425). These medical devices are 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 presents a risk that patients may develop infections.
Approximately 260,395 units were distributed in the United States, with a global total of 7,400,000 units. The affected lots include codes 01K through 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, and 0XV. Healthcare providers and consumers should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - 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
- 09V
- 0XV
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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