Facility

UNETIXS VASCULAR, INC.

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

Key facts

1recalls · worst Class II

6inspections · worst OAI

3warning letters

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

FDA Establishment Identifier (FEI)	1222117
Establishment type	Manufacture Medical Device
Location	333 Strawberry Field Rd Warwick, RI, US 02886
Registration status	Active · expires 2026
Parent company	UNETIXS VASCULAR, INC. (owner-operator 9000359)
Brand names	MultiLab 2000 Series II 2CP-R Express; Miltilab Series 2 LHS-TI; MultiLab 2000 Series II LHS-TI; MultiLab 2000 Series II Roodra; Multilab Series 2-CP-R; Multilab Series 2 LHS ERGO; MultiLab 2000 Series II Revo w/cart; MultiLab 2000 Series II 2CP-R; MultiLab 2000 Series II LHS-TI w/Ergo IDC; REVO 1100; Multilab 2000 Series 2 LHS; Multilab 2000 Series 2-CP-R,

Activity by year

Recalls (1)
Inspections (6)
Warning letters (3)

Devices registered here (1)

Monitor, Ultrasonic, Nonfetal
Product code JAF (opens in a new tab) · Class II · Radiology · 21 CFR 892.1540

Recalls & enforcement

Class IIOngoing2023-02-10
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.

FDA inspections (6)

OAI2025-12-04
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-09-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-07-30
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2019-10-29
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-06-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-03-29
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (3)

Warning Letter2026-04-16
Warning Letter (opens in a new tab) · Warwick Rhode Island
Warning Letter2020-02-04
Warning Letter (opens in a new tab) · Warwick Rhode Island
Warning Letter2017-04-25
Warning Letter (opens in a new tab) · Warwick Rhode Island

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by UNETIXS VASCULAR, 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. “UNETIXS VASCULAR, INC. (FEI 1222117) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1222117-unetixs-vascular-inc/

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