Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration
Mizuho America is recalling 32 units of Sugita Titanium Standard Aneurysm Clip II due to discoloration. The devices are intended for single use in cerebral aneurysms.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text identifies discoloration as the defect but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mizuho America, Inc. is recalling 32 units of the Mizuho Sugita Titanium Standard Aneurysm Clip II. The recall involves specific item numbers from Lots 27-J and 29-J of the Sugita T2 Aneurysm Clips, Mini Temporary Type. The affected devices are discolored.
These medical devices are designed for the temporary and permanent occlusion of the cervical segment of cerebral aneurysms and peripheral blood vessels. They are intended for single use. The recall is classified as Class II by the FDA.
The products were distributed nationwide. The source text does not specify the exact number of units distributed or the specific facilities where they were used. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
- Manufacturer
- Mizuho America, Inc.
- Category
- Medical Device — Neurological
- Hazard
- Affected units
- 32
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 (2)
- Product Code 17-001-56
- Lot No. 27JY
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mizuho America, Inc. 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 2 products in this recall →Related recalls
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