FDA Medical Device Recalls (openFDA)
Healthtronics, Inc.: 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.
- Recall number
- Z-0825-2013
- Recalling firm
- Healthtronics, 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.
- Status
- Terminated
- Initiated
- 2012-12-20
- Posted
- 2013-02-15
- Terminated
- 2013-04-22
- Reason
- The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
- 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
- 50 units
- Distribution
- Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
- Lot, serial or model codes
- Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L
- 510(k) numbers
- ["K101333"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3008262715
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28