Boston Scientific Cork, Ltd. recalls Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser…
Read the official notice →- Date
- 2026-10-28
- Country
- United States
- Brand
- Boston Scientific Cork, Ltd.
- Product
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
- Classification
- Class II
- Units
- Worldwide distribution US Nationwide and territory of Puerto Rico. The…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2026-10-28
Medtronic Neuromodulation recalls InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and territory of Puerto Rico. The…Official notice →Medtronic MiniMed, Inc. recalls Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version:…
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA,…Official notice →restor3d Inc. recalls Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description:…
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
FDA · Devicerestor3d Inc.U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.Official notice →Life Technologies Holdings Pte Ltd recalls Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
DNA or RNA sequencing system software has vulnerabilities.
FDA · DeviceLife Technologies Holdings Pte LtdUS Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ,…Official notice →TECHNO-PATH MANUFACTURING LTD. recalls Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life…
FDA · DeviceTECHNO-PATH MANUFACTURING LTD.US Nationwide distribution in the state of Massachusetts.Official notice →CooperVision, Inc. recalls Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables…
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement…
FDA · DeviceCooperVision, Inc.US Nationwide distribution in the states of FL, KY, MI.Official notice →