Facility

CALYXO, INC.

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

—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)	3032959393
Establishment type	Manufacture Medical Device
Location	4430 Rosewood Dr. Pleasanton, CA, US 94588
Registration status	Active · expires 2026
Parent company	Calyxo, Inc. (owner-operator 10058093)
Brand names	CVAC Aspiration System (CVAC 2.1, K261447); CVAC Image Processor (K233472); CVAC Aspiration System and CVAC Image Processor (K233472); CVAC Image Processor (SW 1.5, K260013)

Activity by year

Recalls (1)

Devices registered here (2)

Ureteroscope And Accessories, Flexible/Rigid
Product code FGB (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Endoscopic Access Overtube, Gastroenterology-Urology
Product code FED (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IOngoing2025-02-19
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or…

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. “CALYXO, INC. (FEI 3032959393) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3032959393-calyxo-inc/

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