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OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device

Official notice

26 Aug 2026

Last checked

22 Sept 2026

MediumFDA

An official FDA notice concerns Boston Scientific. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-08-26. Lots: 36159783, 36179248, 36179249, 36179250, 36179674 and 217 more. Recall numbers: Z-2961-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

60,654

Recall number

Z-2961-2026

Official notice

2026-08-26

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

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

Event Ids

99435

Recall Numbers

Z-2961-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AT · Austria

Affected area 4

BE · Belgium

Affected area 5

BG · Bulgaria

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CL · Chile

Affected area 9

CR · Costa Rica

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

DK · Denmark

Affected area 13

DO · Dominican Republic

Affected area 14

EG · Egypt

Affected area 15

ES · Spain

Affected area 16

FI · Finland

Affected area 17

FR · France

Affected area 18

GB · United Kingdom

Affected area 19

GR · Greece

Affected area 20

HK · Hong Kong

Affected area 21

HR · Croatia

Affected area 22

HU · Hungary

Affected area 23

IE · Ireland

Affected area 24

IL · Israel

Affected area 25

IT · Italy

Affected area 26

JP · Japan

Affected area 27

LV · Latvia

Affected area 28

MT · Malta

Affected area 29

NL · Netherlands

Affected area 30

NO · Norway

Affected area 31

PK · Pakistan

Affected area 32

PL · Poland

Affected area 33

PT · Portugal

Affected area 34

RO · Romania

Affected area 35

RS · Serbia

Affected area 36

SA · Saudi Arabia

Affected area 37

SE · Sweden

Affected area 38

SK · Slovakia

Affected area 39

TH · Thailand

Affected area 40

TW · Taiwan

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific. Contact: Boston Scientific Corporation.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2961-2026

Event id

99435

Units affected

60,654

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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