FDA · Medical devices ·
OverStitch Suture Cinch recall
Boston Scientific Corporation recalled OverStitch Suture Cinch on August 26, 2026 because of device may fail to deploy the cinch implant and/or fail to cut the suture as intended. It was sold nationwide.
Why it was recalled
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
What's recalled
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Quantity: 60,654 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Boston Scientific Corporation, Marlborough, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands… - Status
- Ongoing
- Recall number
- Z-2961-2026
- Source
- U.S. Food and Drug Administration
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