Recall Z-2962-2026
Boston Scientific Corporation · initiated July 14, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Codes / lots: 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.
Reason for recall
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
FDA-determined cause: Under Investigation by firm
Action taken
An Urgent Medical Device Removal notification dated 7/14/26 was mailed to consignees instructing them to immediately stop further use or distribution of affected devices. Consignees are to forward the notice to relevant personnel and to facilities where product was further distributed. Healthcare personnel are to monitor patients that received care with affected devices per the standard of care. The provided response form is to be completed and returned to Boston Scientific, and product returned in accordance with the provided instructions. Consignees with any quality concerns can email BSCComplaints@bsci.com.
Details
- Recall number
- Z-2962-2026
- Initiated
- July 14, 2026
- Posted by FDA
- August 14, 2026
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Quantity
- 60,654 units
- 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…
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2961-2026 Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | 07/14/2026Open, Classified |