Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon — Class II medical device recall Z-0602-2016
Terminated recall by Ethicon, Inc., reported 2016-01-13, distributed nationwide. Stability data does not substantiate the labeled two-year shelf life of affected product.
| Recall number | Z-0602-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2015-12-03 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2017-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AW, BE, BR, CA, CO, EC, IN, MX, SG, VE |
| Quantity | 96,124 units |
| Reason classes | labeling, specification failure |
| Lot numbers | GMMG07, GMMG08, GMMG09, GMMG10, GMMG11, GPMG01, GPMG02, GPMG03, GPMG04, GPMG05, GPMG06, GPMG07, GPMG08, GPMG09, GPMG10, GPMG11, HAMG01, HAMG02, HAMG03, HAMG04, HAMG05, HAMG06, HAMG07, HAMG08, HAMG09, HAMG10, HAMG11, HAMG12, HAMG13, HAMG14, HBMG01, HBMG02, HBMG03, HBMG04, HBMG05, HBMG06, HBMG07, HBMG08, HBMG09, HBMG10 and 176 more |
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 (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Reason for recall
Stability data does not substantiate the labeled two-year shelf life of affected product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0602-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.