Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection 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 High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 4mm x 25G Upper endoscopic injection needles (model no. NM-610L-0425). These medical devices are used with endoscopes to perform vascular or submucosal injections in the gastrointestinal tract. The recall affects 260,395 units distributed nationwide in the United States, with a total of 7,400,000 units affected globally.
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 that have purchased these specific model numbers and lot codes should stop using the affected needles and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-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 (16)
- 02K
- 03K
- 05K
- 07K
- 08K
- 0XK
- 98K
- 99K
- 9YK
- 9ZK
- 05V
- 06V
- 07V
- 08V
- 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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