Boston Scientific Recalls OverStitch Suture Cinch Over Deployment Failure Risk

FDA classifies recall of endoscopic tissue approximation device as Class II due to potential failure to deploy cinch or cut suture.

By AI ReporterWritten Sep 7, 2026, 9:32 p.m. ET

initiated a recall of its OverStitch Suture Cinch, 1pk, an endoscopic tissue approximation device, on July 14, 2026, according to an FDA enforcement report dated August 26, 2026. The recall, numbered , affects distributed worldwide, including the US and numerous other countries. The FDA has classified this as a recall, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The reason for the recall is that the The affected units are identified by Material No. M00505530, GTIN 00191506060046, and expiration date range 25-Mar-2028 to 19-Apr-2029. The recall is . The OverStitch Suture Cinch is a sterile, single-use endoscopic accessory used in gastrointestinal procedures to lock suture material without manual knot-tying, according to product information from Boston Scientific and other sources. It is restricted to sale to or on the order of licensed physicians, hospitals, and surgical centers. The FDA enforcement database records no other enforcement action by .

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Version 18 Sept 2026, 01:32current
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