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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 infection from non-sterile equipment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 6MMx 25G UPPER endoscopic injection needles (model no. NM-610L-0625). These 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, 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 equipment in these procedures may lead to patient infections.
The affected products were distributed nationwide in the US. The specific lot codes involved are 05V, 06V, 07V, 08V, 09V, and 0XV. Healthcare providers and consumers should stop using these needles and contact the manufacturer for further instructions.
The recalled product
- Product
- NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - 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 (6)
- 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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