Facility

UNIMAX MEDICAL SYSTEMS INC.

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3015497424
Establishment type	Manufacture Medical Device
Location	No. 37, Sec. 2, Ligong 1st Rd., Wujie Township Yilan County, TW 26841
Registration status	Active · expires 2026
Parent company	Unimax Medical Systems Inc. (owner-operator 10028682)
Brand names	Veress Needle

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Insufflator, Laparoscopic
Product code HIF (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.1730
Pneumoperitoneum Needle
Product code FHO (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IIOngoing2024-06-25
The tube may fall into the surgical site during the grasping process.

FDA inspections (1)

VAI2025-03-06
Voluntary 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.

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. “UNIMAX MEDICAL SYSTEMS INC. (FEI 3015497424) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015497424-unimax-medical-systems-inc/

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