Aomori Olympus Recalls KD-620LR Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-620LR Electrosurgical Snare units because inspection found 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 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 KD-620LR Electrosurgical Snare, model no. KD-620LR. This medical device is used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. The recall involves 260,395 units distributed in the United States, with 7,400,000 units affected globally. The affected units are identified by lot codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recall was initiated after inspection confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.
Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on return or replacement. Consumers should not use these devices if they are in their possession.
The recalled product
- Product
- KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive 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 (15)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
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