Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon Recalled by Ethicon, Inc. Due to Stability data does not substantiate the labeled two-year...
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 Ethicon, Inc. directly.
Affected Products
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Quantity: 96,124 units
Why Was This Recalled?
Stability data does not substantiate the labeled two-year shelf life of affected product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ethicon, Inc.
Ethicon, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report