HealthTronics Endocare 3 — Class II medical device recall Z-0825-2013
Terminated recall by Healthtronics, Inc., reported 2013-02-27, distributed nationwide. The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect
| Recall number | Z-0825-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Healthtronics, Inc., Austin, TX, United States |
| Recall initiated | 2012-12-20 |
| Classified | 2013-02-15 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2013-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 50 units |
| Reason classes | labeling |
| Lot numbers | 10180, 2105-07 |
| Model numbers | R3.8L |
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.
Reason for recall
The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
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-0825-2013. 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.