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 if non-sterile equipment is used.
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, and the hazard involves a risk of infection from non-sterile equipment. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NeedleMaster 5mm x 25G Lower endoscopic injection needles (model no. NM-610U-0525). These devices are used with endoscopes to perform endoscopic vascular or submucosal injection in the gastrointestinal tract. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The products were distributed nationwide in the US.
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 equipment due to these seal defects may result in patients developing infections.
Healthcare facilities and consumers should stop using the affected NeedleMaster needles immediately. The affected lots are identified by the following codes: 01K, 02K, 03K, 04K, 05K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, and 0XV. Users should contact Aomori Olympus Co., Ltd. for further instructions on returning or replacing the devices.
The recalled product
- Product
- NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-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 (19)
- 01K
- 02K
- 03K
- 04K
- 05K
- 08K
- 09K
- 0XK
- 98K
- 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.
See all 111 products in this recall →Related recalls
Same manufacturer · Aomori Olympus Co., Ltd.
See all →- HighReusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
FDA (Devices) · 2023-09-13
- HighOlympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels
FDA (Devices) · 2023-09-13
- HighAomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects
FDA (Devices) · 2021-02-17
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19