FDA Medical Device Recalls (openFDA)
Mizuho America, Inc.: 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.
- Recall number
- Z-0378-2014
- Recalling firm
- Mizuho America, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-10-10
- Posted
- 2013-11-22
- Terminated
- 2014-01-13
- Reason
- Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
- Root cause
- Process control
- Action
- Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice. For questions regarding this recall call 510-324-4500, ext 122.
- Quantity
- 35
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Product Code 17-001-58; Lot No. 29JY
- 510(k) numbers
- ["K990202"]
- PMA numbers
- not on file
- Product code
- HCH
- Firm FEI
- 1000159388
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28