Suture Cinch Long 1pk. Endoscopic tissue approximation… recallZ-2962-2026 · Boston Scientific Corporation · initiated Jul 14, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number: Z-2962-2026
Status: Open, Classified
Initiated by the company: Jul 14, 2026
Posted by the FDA: Aug 14, 2026
Recalling firm: Boston Scientific Corporation
Quantity: 60,654 units
Product code: OCW
FDA submissions: K181141, K201808
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.

Product description

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA M00505550
Boston Scientific Corporation · Endoscopic tissue approximation device
1 recall9 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99435).

Z-2961-2026 · Open, Classified
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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