Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Ebb Complete Tamponade System Recalled by Clinical Innovations, LLC Due to Clinical Innovations, LLC is voluntarily recalling the Ebb...
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 Clinical Innovations, LLC directly.
Affected Products
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Quantity: 827 units
Why Was This Recalled?
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Clinical Innovations, LLC
Clinical Innovations, LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report