Z-0825-2013Class II

HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe...

Name: Z-0825-2013 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe...
Creator: Healthtronics, Inc.
Published: 2012-12-20
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-12-20 / Terminated / root cause: labeling and UDI

FDA source

Healthtronics, Inc. began a recall of HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for... on 2012-12-20. FDA classified it as Class II and gives the reason as "The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0825-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-02-15
Terminated: 2013-04-22
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
Product codes and lots: Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15

Product code GEH

K101333Class IICryocare Cs Surgical SystemEndocare, Inc. / cleared 2010-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)