Fifteen millimetre snares recalled over holes compromising package sterility
Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.
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: Scored 3 under the risk-of-harm criterion: a breached sterile barrier on an endoscopic instrument creates an infection risk, and no injuries are reported.
Plain-English summary
The Olympus Single Use Electrosurgical Snare SD-400, model SD-400U-15, is being recalled. The instruments are designed for use with an Olympus endoscope for the removal of tissue.
Sterility is compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
The recall covers 18,174 units across lots including 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V and 39V. Distribution was worldwide, including nationwide in the United States and to Guam and the Northern Mariana Islands. The FDA has classified the action as Class II.
A breached pouch means the snare may not be sterile when opened for an endoscopic procedure. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Olympus' instructions.
The recalled product
- Product
- Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 18,174
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)
- Model: SD-400U-15
- Lot Numbers: 27V
- 28V
- 29V
- 2XV
- 2YV
- 2ZV
- 31V
- 32V
- 33V
- 34V
- 35V
- 36V
- 37V
- 38V
- 39V
- 3XV
- 3YV
- 3ZV
- 41V
Distribution
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas 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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Same hazard · packaging holes
See all →- HighElectrosurgical snares recalled over small holes compromising package sterility
FDA (Devices) · 2025-11-19
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