Boston Scientific Corporation recalls Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Recalling company

Boston Scientific Corporation

Product

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Reason

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 14, 2026

Reported

Aug 26, 2026

Distribution

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, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.

Status

Ongoing

Quantity

60,654 units

Lot / codes

Material No. M00505550; GTIN: 00191506049188; Lot No. 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759, 37019868, 37031959, 37073352, 37086263, 37096406, 37108084, 37116726, 37124788, 37126750, 37128111, 37302211, 37399016, 37533710, 37586915, 37604205, 37663465, 38587149,38598199, 38823176, 38833088, 39053113, 39091844; Exp. Date Range: 26-Feb-2028 to 14-Apr-2029.

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2962-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2962-2026 in the FDA Enforcement Report. Also see FDA recall press releases.