Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and Recalled by Stradis Healthcare Due to Potential for the outer bag having pinhole leaks...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stradis Healthcare directly.
Affected Products
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Quantity: 920 units
Why Was This Recalled?
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stradis Healthcare
Stradis Healthcare has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report