Fortress Introducer Sheath System Recalled for Incorrect Pouch Label
Fortress Introducer Sheath System units may have been packaged with pouch labels showing incorrect device size information, affecting 2,500 units distributed in the US and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error where pouch labels indicate an incorrect device size (4F versus 6F). The source reports no illnesses, injuries, or deaths. The issue is a packaging/labeling problem rather than a defect in the device itself, fitting the rubric criterion for minor labeling errors.
Plain-English summary
The FDA is recalling Fortress Introducer Sheath System, Model 386594 (6F Straight 45cm), manufactured by Contract Medical International GmbH, due to incorrect pouch labeling. Approximately 2,500 units may have been packaged with labels listing the reference number and unique device identifier of the 4F version rather than the 6F version contained in the package.
The recalled units were distributed worldwide, including in the US states of California, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Michigan, Missouri, New Jersey, New York, Oregon, Rhode Island, South Carolina, Tennessee, and Texas, as well as in Europe and other countries including Switzerland, Hungary, Italy, France, Denmark, Austria, and others. The affected lot number is 800989, with an expiration date of October 31, 2027.
Healthcare providers who have received this product should verify the actual device size before use and contact the manufacturer if they have questions about their supply.
The recalled product
- Product
- Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
- Manufacturer
- Contract Medical International GmbH
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03