Aomori Olympus NeedleMaster Endoscopic Injection Needles Recalled for Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because inspection found inadequate package 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 is classified as FDA Class II. The hazard involves a risk of infection from non-sterile equipment, which is a significant health risk, but the source text does not report any specific illnesses or injuries, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 4MMx 26G UPPER (model no. NM-610L-0426) endoscopic injection needles. These devices are used with endoscopes to perform endoscopic vascular or submucosal injection in the gastrointestinal tract. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The product was distributed nationwide in the US.
The recall was initiated after inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The source text notes that patients may develop infections if non-sterile equipment is used. The affected lot codes are 01K, 02K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, and 0XV.
Healthcare providers and facilities should check their inventory for the affected model and lot codes. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not provide specific instructions for consumers, as this is a medical device used in clinical settings.
The recalled product
- Product
- NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - 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 (19)
- 01K
- 02K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 98K
- 99K
- 9XK
- 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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