Aomori Olympus Crescent Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling Crescent Snare devices due to inadequate package seals that may compromise sterility, 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 CRESCENT SNARE, model no. SD-221U-25, a medical device used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall affects 260,395 units in the United States, with a total of 7,400,000 units distributed globally. The devices were distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. This defect may compromise the sterility of the equipment. If non-sterile equipment is used, patients may develop infections.
Healthcare providers and consumers should stop using the affected devices immediately. Affected lots are identified by the following codes: 01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK. Users should contact the recalling firm for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the 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 (20)
- 01K
- 02K
- 03K
- 04K
- 05K
- 07K
- 08K
- 09K
- 0XK
- 92K
- 93K
- 94K
- 95K
- 96K
- 97K
- 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