FDA Medical Device Recalls (openFDA)
Endocare, Division Of Healthtronics: Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
- Recall number
- Z-0615-2011
- Recalling firm
- Endocare, Division Of Healthtronics
- Product
- Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
- Status
- Terminated
- Initiated
- 2010-11-04
- Posted
- 2010-12-13
- Terminated
- 2011-04-14
- Reason
- Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe).
- Root cause
- Other
- Action
- Healthronics issued an Urgent Device Recall letter dated November 2, 2010 to consignees. The letter described the product mislabeling, and requested customers to examine their inventory, quarantine all affected product, and complete and return the verfication section of the letter to the firm. A return authorization number and prepaid return label were provide to facilitate return and replacement. Healthronics can be contacted at 877 367-4873 concerning this recall.
- Quantity
- 33 Units
- Distribution
- Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.
- Lot, serial or model codes
- Part #CRYO-44F. Lot 2751. 510(K): K060279. Product Code: GEH.
- 510(k) numbers
- ["K060279"]
- 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