Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Lot codes and dates
- Material No. M00505530
- GTIN
224 of 224 codes
00191506060046Lot No. 3615978336179248361792493617925036179674361811533619358536195262361952813621313036213131362224333622311036233350362334233623342436238771362464773624774436247745362571443625714536264795362666043628530336285304362910943629114236296642362977183629878536299374363072863633509836336245363362463633624736336248363362493634954336358240363664103636888036370038363764933639071636400755364138323642943836440653364406593644079836441070364413903644393336450076364513983645206136454608
- Amount recalled
- 60,654 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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