W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to…
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- W L Gore & Associates
- Product
- GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
- Classification
- Class II
- Units
- US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 W L Gore & Associates recalls
- 2026-08-19
USW L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain…
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
FDA · DeviceW L Gore & Associates, Inc.U.S. Nationwide distribution in the states of GA and RI.Official notice →- 2026-07-08
- US
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and…
Due to catheter separation
FDA · DeviceW L Gore & Associates, Inc.Worldwide - U.S. Nationwide distribution including in the states and…Official notice → - 2024-09-11
- US
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-08-14
- US
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.Official notice → - 2024-02-28
- US
W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2)…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary…
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the state of Georgia.Official notice → - 2023-02-08
- US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could…
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-08
- US
Draeger, Inc. recalls Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan…
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger, Inc.Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the…Official notice → - US
Medline Industries, LP recalls Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH…
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk…
FDA · DeviceMedline Industries, LPDomestic US distribution nationwide. International distribution pending. No…Official notice → - US
Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Convenience kits labeled as sterile have not gone through the sterilization process.
- US
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8)…
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice → - US
Medtronic MiniMed, Inc. recalls Medtronic, Simplera Sensor, REF: MMT-5100JD1
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA · DeviceMedtronic MiniMed, Inc.US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United…Official notice → - US
Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…
FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →