FDA recall, , Moderate risk
Boston Scientific OverStitch Suture Cinch and Suture Cinch Long
The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Marlborough, Massachusetts, recalled the OverStitch Suture Cinch and Suture Cinch Long, both endoscopic tissue approximation devices, because the devices may fail to deploy the cinch implant and/or fail to cut the suture as intended. The company began the recall on July 14, 2026, and the FDA added it to the Enforcement Report on August 14, 2026. Distribution was worldwide, including the US Nationwide and numerous countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
Incomplete list: 80 of 284 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- UDI-DI
- 00191506060046
- 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
- Lot code
- 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
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
- UDI-DI
- 00191506049188
- 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
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
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.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99435
- Recall numbers
- Z-2961-2026 to Z-2962-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
