Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration
Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.
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 2/5 (Moderate).
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, but the source text explicitly states no illnesses or injuries have been reported and the hazard (discoloration) is a quality defect without immediate reported harm, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mizuho America, Inc. is recalling 35 units of the Mizuho Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58. The affected products are identified by Product Code 17-001-58 and Lot No. 29JY. The recall is due to discoloration observed in specific item numbers from Lots 27-J and 29-J of the Sugita T2 Aneurysm Clips, Mini Temporary Type.
These medical devices are designed for the temporary and permanent occlusion of the cervical segment of cerebral aneurysms and peripheral blood vessels and are intended for single use. The products were distributed nationwide.
Healthcare facilities and distributors should stop using the affected lots and contact Mizuho America, Inc. for further instructions. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
- Manufacturer
- Mizuho America, Inc.
- Affected units
- 35
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 17-001-58
- Lot No. 29JY
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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