Z-2962-2026Class II

Suture Cinch Long 1pk. Endoscopic tissue approximation device

Name: Z-2962-2026 Suture Cinch Long 1pk. Endoscopic tissue approximation device
Creator: Boston Scientific Corporation
Published: 2026-07-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-07-14 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of Suture Cinch Long 1pk. Endoscopic tissue approximation device on 2026-07-14. FDA classified it as Class II and gives the reason as "Device may fail to deploy the cinch implant and/or fail to cut the suture as intended". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2962-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-14
Posted: 2026-08-14
Recalling firm: Boston Scientific Corporation
Product: Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Product code: OCW Endoscopic Tissue Approximation Device
Reason for recall: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2962-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2961-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2962-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code OCW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)