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 involves a risk-of-harm product (infection from non-sterile equipment) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 4MMx 21G UPPER endoscopic injection needles (model no. NM-610L-0421). These devices are used with endoscopes to perform endoscopic vascular or submucosal injection in the gastrointestinal tract. The recall affects 260,395 units distributed in the United States, with 7,400,000 units affected globally. The affected units are identified by the following lot codes: 03K, 04K, 08K, 05V, 06V, 07V, 08V, 09V, and 0XV.
The recall was initiated after inspections confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. This defect compromises the sterility of the equipment. If non-sterile equipment is used during a procedure, patients may develop infections.
Healthcare providers and facilities that have received these products should stop using them immediately. They should contact Aomori Olympus Co., Ltd. for instructions on how to return or dispose of the affected units. Patients who have had procedures using these specific needles should contact their healthcare provider if they experience signs of infection.
The recalled product
- Product
- NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - 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 (9)
- 03K
- 04K
- 08K
- 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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