Quick Facts at a Glance
- Recall Date
- July 30, 2025
- Hazard Level
- HIGH
- Brands
- Fortress Introducer Sheath System, Contract Medical International GmbH
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fortress Introducer Sheath System, Contract Medical International GmbH
- Product type
- Introducer Sheath System
- Model numbers
- 386594
- Sizes
- 6F Straight 45cm
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 30, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Contract Medical International GmbH or your healthcare provider for instructions. Notification method: E-Mail
About This Product
Introducer sheath systems are used to facilitate percutaneous access during cardiovascular procedures. This recall centers on labeling accuracy, not device performance.
Why This Is Dangerous
Mislabeled packaging could lead to use of the wrong device specification, risking procedural errors.
Industry Context
This recall is not part of a broader pattern of device failures; it concerns labeling accuracy.
Real-World Impact
Medical staff must verify labeling to avoid incorrect device selection during procedures; no injuries reported in the release.
Practical Guidance
How to identify if yours is affected
- Verify pouch label reference matches the packaged device (6F Straight 45cm).
- Cross-check with the model number 386594.
- Review packaging labels before use in any procedure.
Where to find product info
FDA recall page and manufacturer instructions; check the recall notice and email communications.
What timeline to expect
Recall was active as of 2025-07-30; processing times for replacement or refund are not specified.
If the manufacturer is unresponsive
- Escalate to FDA recall contacts if the manufacturer does not respond within a reasonable time.
- Document all attempts to contact the manufacturer.
How to prevent similar issues
- Institute labeling verification step in procurement and receiving.
- Train staff on recognizing when pouch labels do not match the device.
- Maintain an up-to-date recall log for medical devices.
Documentation advice
Keep copies of recall notices, labeling discrepancies, and correspondence with the manufacturer.
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Product Details
Brand: Fortress Introducer Sheath System. Model/Catalog: 386594. Description: 6F Straight 45cm. Quantity: 2,500. Distribution: Worldwide. US distribution in CA, CT, FL, GA, KY, MA, MI, MO, NJ, NY, OR, RI, SC, TN, TX; countries: Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden. Classification: Class II.
Reported Incidents
No incident count is provided in the recall notice. No injuries or incidents are mentioned in the document provided.
Key Facts
- Worldwide distribution including 15 U.S. states and multiple countries
- Labeling error ties 6F device to 4F identifiers
- Class II medical device
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Safety Guide
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