Class II — CSA Medical
| Recalling firm | CSA MEDICAL, INC. |
|---|---|
| Registered facility | CSA Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax |
| Product | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 |
| Quantity | 82 units |
| Distribution | Nationwide |
| Initiated | 2015-03-25 |
| Classified | 2015-04-23 |
| Terminated | 2015-08-21 |
| Recall number | Z-1513-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CSA Medical (Z-1513-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70851/
Alerts for CSA MEDICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.