Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mederi Stretta Catheter and Accessory Kit Recalled by Mederi Therapeutics, Inc Due to Product sterility compromised due to breach in sterile...
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 Mederi Therapeutics, Inc directly.
Affected Products
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Quantity: 1458 units
Why Was This Recalled?
Product sterility compromised due to breach in sterile barrier package
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mederi Therapeutics, Inc
Mederi Therapeutics, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report