FDAFDA recall Z-2961-2026 · Aug 26, 2026

Boston Scientific Corporation: OverStitch Suture Cinch recall

Recall found

Product

OverStitch Suture Cinch, 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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: Material No. M00505530; GTIN: 00191506060046; Lot No. 36159783, 36179248, 36179249, 36179250, 36179674, 36181153, 36193585, 36195262, 36195281,36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744, 36247745, 36257144, 36257145, 36264795, 36266604, 36285303, 36285304, 36291094, 36291142, 36296642, 36297718, 36298785, 36299374, 36307286, 36335098, 36336245, 36336246, 36336247, 36336248, 36336249, 36349543, 36358240, 36366410, 36368880, 36370038, 36376493, 36390716, 36400755, 36413832, 36429438, 36440653, 36440659, 36440798, 36441070, 36441390, 36443933, 36450076, 36451398, 36452061, 36454608, 36454861, 36461432, 36466525, 36472307, 36472448, 36472813, 36473087, 36475081, 36482317, 36482413, 36482837, 36482838, 36486869, 36488822, 36496658, 36498004, 36500343, 36500745, 36508877, 36509436, 36511012, 36519283, 36519622, 36564120, 36567088, 36567089, 36651483, 36651990, 36660007, 36670672, 36689082, 36691535, 36691536, 36692473, 36715146, 36715947, 36722429, 36733894, 36736063, 36737026, 36742475, 36747253, 36754086, 36756476, 36767158, 36770136, 36795290, 36802913, 36816032, 36816864, 36819466, 36829515, 36837613, 36840422, 36855429, 36859432, 36870323, 36884519, 36886399, 36887192, 36894183, 36906859, 37049911, 37053262, 37063221, 37071091, 37082225, 37256930, 37258435, 37265997, 37268058, 37276648, 37277853, 37332709, 37335148, 37341879, 37431423, 37462817, 37475144, 37479080, 37512600, 37516705, 37538409, 37614916, 37628854, 37701281, 37712590, 37747392, 37759135, 37768422, 37780435, 37804241, 37813732, 37824328, 37846636, 37861753, 37874884, 37906665, 37952534, 37976914, 37980916, 37987576, 38001581, 38020339, 38045267, 38055953, 38064514, 38087625, 38092029, 38119620, 38134479, 38149599, 38168976, 38265895, 38274202, 38277823, 38298897, 38307807, 38355532, 38404637, 38421970, 38438020, 38441891, 38448572, 38458999, 38480821, 38495024, 38498977, 38505659, 38526386, 38527090, 38540408, 38613546, 38620724, 38629370, 38672064, 38682255, 38692722, 38709195, 38711985, 38728857, 38738005, 38748320, 38759951, 38771565, 38787506, 38798542, 38808911, 38847193, 38866237, 38886764, 38917596, 38926776, 38936218, 38939941, 38948809, 39018825, 39029561, 39032429, 39043147, 39095582, 39114250, 39131778; Exp. Dat Range 25-Mar-2028 to 19-Apr-2029.
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, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
Recalling firm: Boston Scientific Corporation, Marlborough, MA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-14

Source: openFDA enforcement record Z-2961-2026 · search recall number Z-2961-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.