RecallRadar

FDA Device recall Z-0825-2013

HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Su…

On 2013-02-27 the FDA classified a Class II recall of HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Su… by Healthtronics, citing the Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0825-2013
ClassificationClass II
Statusterminated
Initiated2012-12-20
Published2013-02-27
Last updated2026-09-13 11:53 UTC
CompanyHealthtronics
DistributionUS

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

The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

Identifiers

code_infoLot 10180, Expiration date on box is 2105-07. Model Number R3.8L

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.