Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles for 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 (infection) from non-sterile equipment, but the source text does not report any actual illnesses 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 4MMx 26G LOWER (model no. NM-610U-0426) endoscopic injection needles. These devices are used with endoscopes to perform vascular or submucosal injection in the gastrointestinal tract. The recall affects 260,395 units 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 sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile medical equipment can lead to patient infections.
The affected products were distributed nationwide in the United States. Specific lot codes involved in the recall include 01K through 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, and 0XV. Healthcare facilities and consumers should stop using these specific needles and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-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 (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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