FDA Medical Device Recalls (openFDA)
Healthtronics, Inc.: CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
- Recall number
- Z-1275-2012
- Recalling firm
- Healthtronics, Inc.
- Product
- CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
- Status
- Terminated
- Initiated
- 2012-02-27
- Posted
- 2012-03-21
- Terminated
- 2013-03-19
- Reason
- HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.
- Root cause
- Labeling mix-ups
- Action
- Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification Section on page two, and 3) Return this letter with the affected product to the address provided. For questions about this recall contact Endocare, Inc at 877-367-4873.
- Quantity
- 9274 units
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.
- Lot, serial or model codes
- Multiple codes.
- 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