Class II — Healthtronics, Inc.
| Recalling firm | HealthTronics, LLC |
|---|---|
| Registered facility | HealthTronics, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. |
| Product | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI |
| Initiated | 2012-12-20 |
| Classified | 2013-02-15 |
| Terminated | 2013-04-22 |
| Recall number | Z-0825-2013 |
| 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 — Healthtronics, Inc. (Z-0825-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63933/
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