Ethicon Recalls Gynecare Thermachoice III Uterine Balloon Therapy System
Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System because stability data does not support the labeled two-year shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling/shelf-life discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System. This thermal balloon ablation device is 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.
The recall was initiated because stability data does not substantiate the labeled two-year shelf life of the affected product. The source text does not report any specific illnesses, injuries, or deaths associated with the use of this device.
Approximately 96,124 units were distributed worldwide, including the United States (nationwide including Puerto Rico) and countries such as India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba, and Venezuela. Specific lot and batch codes are listed in the agency's structured data. Consumers and healthcare providers should contact Ethicon, Inc. for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- 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 (exc
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Gynecological
- Hazard
- Affected units
- 96,124
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- TC003 (US Only) TC013 (US Only) TC033 (OUS Only) TC043 (OUS Only). Code
- Batch: TC04320
- GMMG07
- TC00320
- GMMG08
- GMMG09
- GMMG10
- TC04320
- GMMG11
- TC03320
- GPMG01
- GPMG02
- GPMG03
- GPMG04
- GPMG05
- TC01320
- GPMG06
- GPMG07
- GPMG08
- GPMG09
Distribution
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