Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects
Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because some sterile packages have inadequate seals, posing a risk of infection.
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: 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 SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m endoscopic snare. This medical device is used with endoscopes for the removal and/or cauterization of polyps and tissue from within the gastrointestinal tract. The recall affects 260,395 units distributed in the United States, with 7,400,000 units affected globally.
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.
The affected product codes are 97V, 98V, 9XV, 9YV, 03V, 05V, and 06V. The product was distributed nationwide in the US. Healthcare providers and patients should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within 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 (7)
- 97V
- 98V
- 9XV
- 9YV
- 03V
- 05V
- 06V
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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