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 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 from non-sterile equipment) where no specific injuries or illnesses have been reported yet, fitting the 'High' severity criteria for theoretical hazards.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 5MMx 25G UPPER (model no. NM-610L-0525) endoscopic injection needles. These devices are used with endoscopes to perform vascular or submucosal injections in the gastrointestinal tract. The recall affects 260,395 units distributed in the United States, with an additional 7,400,000 units affected globally.
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 medical equipment can lead to patient infections.
Healthcare providers and facilities should stop using the affected needles and contact the manufacturer for further instructions. The affected lot codes are 01K, 02K, 03K, 04K, 05K, 0XK, 98K, 99K, 9XK, 9ZK, 05V, 06V, 07V, 08V, 09V, and 0XV.
The recalled product
- Product
- NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - 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)
- 01K
- 02K
- 03K
- 04K
- 05K
- 0XK
- 98K
- 99K
- 9XK
- 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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