Facility

CSA Medical

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010140265
Establishment type	Manufacture Device in the United States for Export Only
Location	131 Hartwell Ave Lexington, MA, US 02421
Registration status	Active · expires 2026
Parent company	CSA MEDICAL, INC. (owner-operator 9062377)
Brand names	RejuvenAir

Activity by year

Recalls (2)

Devices registered here (1)

Unit, Cryosurgical, Accessories
Product code GEH (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4350

Recalls & enforcement

Class IITerminated2015-03-25
TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
Class IITerminated2014-11-10
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

All facilities operated by CSA MEDICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CSA Medical (FEI 3010140265) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010140265-csa-medical/

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