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…
Read the official notice →- Date
- 2026-09-23
- Country
- United States
- Brand
- Boston Scientific
- Product
- Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AZ, FL, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-30
USBoston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and territories of Puerto Rico and the countries of…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 → - US
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.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Austria,…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 →
Other drugs & medical recalls in the United States
- 2026-09-23
- US
Howmedica Osteonics Corp. recalls SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, LATAM,…Official notice → - US
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
FDA · DeviceMirion Technologies (Capintec), Inc.Worldwide distribution - US Nationwide and the countries of ALGERIA, AUSTRIA,…Official notice → - US
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…
- US
Stryker Sustainability Solutions recalls REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Reusable access port system may crack or seperate during use.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution including in the states of Alabama, Alaska,…Official notice → - US
Medical Action Industries, Inc. 306 recalls Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection…
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may…
FDA · DeviceMedical Action Industries, Inc. 306US Nationwide distribution in the states of OH, IN, NC.Official notice → - US
embecta Medical II LLC recalls EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
FDA · Deviceembecta Medical II LLCUS Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA,…Official notice →