Home / Recalls / Boston Scientific Corporation / Z-2962-2026

Z-2962-2026 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

FDA device recall Z-2962-2026 was initiated by Boston Scientific Corporation on July 14, 2026 and is designated Class II. Reason for recall: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. The recall status is ongoing. Affected quantity: 60,654 units.

Recall Details

Product Type
Devices
Report Date
August 26, 2026
Initiation Date
July 14, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,654 units

Product Description

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Reason for Recall

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

Distribution Pattern

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.

Code Information

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.

Other recalls by Boston Scientific Corporation

  • Z-3081-2026 Class II — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C (August 6, 2026)
  • Z-3082-2026 Class II — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C (August 6, 2026)
  • Z-3083-2026 Class II — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C (August 6, 2026)
  • Z-3188-2026 Class II — Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power C (July 22, 2026)
  • Z-2961-2026 Class II — OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. (July 14, 2026)
  • Z-2978-2026 Class I — Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Nu (July 9, 2026)
  • Z-2977-2026 Class I — Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number (July 9, 2026)
  • Z-2839-2026 Class II — Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and U (June 30, 2026)
  • Z-2838-2026 Class II — Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an (June 30, 2026)
  • Z-2725-2026 Class II — Rapid Refill Continuous Injection System, UPN M00566001 (June 30, 2026)

FDA data resources