CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Mizuho Sugita Titanium Standard Aneurysm Clip II recalled
Mizuho America is recalling Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of, distributed nationwide in the US. The recall was initiated on 10 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0377-2014
- FDA event ID
- 66561
- Recalling firm
- Mizuho America, Union City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2013
- FDA classified
- 22 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2013 | Recall initiated by company | |
| 22 Nov 2013 | Classified by FDA | +43 days |
| 4 Dec 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
Which lots are affected?
Product Code 17-001-56; Lot No. 27JY
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66561| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mizuho Sugita Titanium Standard Aneurysm Clip II recalled | Mizuho America | Other | Nationwide |
More recalls from Mizuho America
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Microsurgical Operating Room Tables;7300B (18-350-70) recalled | Mizuho America | Other | 9 states |
| Device | CLASS II | Microsurgical Operating Room Tables;7300BX (18-351-70) recalled | Mizuho America | Other | 9 states |
| Device | CLASS II | Mizuho Sugita Titanium Standard Aneurysm Clip II recalled | Mizuho America | Other | Nationwide |
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