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 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 does not report specific hospitalizations or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 5mm x 21G Upper endoscopic injection needles (model no. NM-610L-0521). These medical devices are used with endoscopes to perform vascular or submucosal injections in the gastrointestinal tract. The recall involves 260,395 units in the United States, which were distributed nationwide.
The recall was initiated after inspections confirmed that a small percentage of the sterile packages have inadequate seals, specifically partial heat seals. The use of non-sterile equipment can lead to patient infections.
Healthcare providers and facilities should stop using the affected needles and contact the manufacturer for instructions on how to return or dispose of the product. Patients who have received injections using these devices should contact their healthcare provider if they experience signs of infection.
The recalled product
- Product
- NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - 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 (12)
- 01K
- 05K
- 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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