CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical… — Class II medical device recall Z-1513-2015
Terminated recall by CSA Medical, reported 2015-04-29, distributed nationwide. TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,s
| Recall number | Z-1513-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CSA Medical, Lexington, MA, United States |
| Recall initiated | 2015-03-25 |
| Classified | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 82 units |
| Serial numbers | 01-00106 |
| Model numbers | CC3-01 |
Product
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Reason for recall
TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1513-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.