Class II — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Stability data does not substantiate the labeled two-year shelf life of affected 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 (excessive uterine bleeding) due to benign causes for whom childbearing is complete. |
| Quantity | 96,124 units |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela. |
| Initiated | 2015-12-03 |
| Classified | 2016-01-06 |
| Terminated | 2017-05-30 |
| Recall number | Z-0602-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ethicon, Inc. (Z-0602-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72840/
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