Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 bleed — recall Z-0602-2016

U.S. FDA — Device Enforcement · United States · 2015-12-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0602-2016
Date of alert: 2015-12-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices

Reported risk: Stability data does not substantiate the labeled two-year shelf life of affected product.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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