Boston Scientific Corporation recalls OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Read the official notice →- Date
- 2026-08-26
- Country
- United States
- Brand
- Boston Scientific
- Product
- OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Austria,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Boston Scientific recalls
- 2026-09-23
US
Boston Scientific Corporation recalls Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to…
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during…
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution including in the states of AZ, FL, CA,…Official notice →- 2026-09-09
US
Boston Scientific Corporation recalls LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical…
- 2026-08-26
US
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
FDA · DeviceBoston Scientific CorporationWorldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →- 2026-08-12
US
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN:…
Potential for breach in sterile barrier of device packaging.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice →- 2026-07-29
US
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice →US
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
Other drugs & medical recalls in the United States
- 2026-08-26
US
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
FDA · DeviceSiemens Healthcare Diagnostics Products Ltd.Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the…Official notice →US
AVID Medical, Inc. recalls Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
US
Maquet Critical Care AB recalls GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use.…
The module did not undergo electrical safety tests and functional tests during production.
FDA · DeviceMaquet Critical Care ABUS Nationwide distribution in the states of CA, GA, MN, NY.Official notice →US
Tobii Dynavox Llc recalls TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and…
US
Arrowhead DE LLC recalls Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550,…
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
FDA · DeviceArrowhead DE LLCUS Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.Official notice →US
Kico Knee Innovation Company recalls Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software…
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
FDA · DeviceKico Knee Innovation CompanyConsignee Consignee Number Region Device Quantity RFK MEDICAL CE102 RICHMOND…Official notice →