Drugs & medicalClass II

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…

Read the official notice →
Date
2026-09-09
Country
United States
Brand
Boston Scientific
Product
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Classification
Class II
Units
Worldwide - US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-09-30
  2. US
    Drugs & medicalClass I

    Boston 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 →
  3. 2026-09-23
  4. US
    Drugs & medicalClass II

    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 →
  5. 2026-08-26
  6. US
    Drugs & medicalClass I

    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 →
  7. US
    Drugs & medicalClass II

    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 →
  8. 2026-08-12
  9. US
    Drugs & medicalClass II

    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 →
  10. 2026-07-29
  11. US
    Drugs & medicalClass II

    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 →
All 68 Boston Scientific recalls →

Other drugs & medical recalls in the United States

  1. 2026-09-09
  2. US
    Drugs & medicalClass II

    B Braun Medical Inc recalls Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

    Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

    FDA · DeviceB Braun Medical IncWorldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI,…Official notice →
  3. US
    Drugs & medicalClass II

    Medos International Sarl recalls Velys Enabling Tech Robotic-Assist Station REF: 451611001

    Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

    FDA · DeviceMedos International SarlUS Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ,…Official notice →
  4. US
    Drugs & medicalClass II

    Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

    Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

    FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCWorldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA,…Official notice →
  5. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE…

    Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially…

    FDA · DeviceMedline Industries, LPUS Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

    A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
  7. US
    Drugs & medicalClass II

    Johnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF:…

    Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the…

    FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of PA, AL, AZ,…Official notice →
See all drugs & medical recalls →