Facility

UNIMAX MEDICAL SYSTEMS INC.

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

Key facts

1recalls · 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)	3007791595
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Develop Specifications But Do Not Manufacture At This Facility
Location	8F-2, No. 127, Lane 235, Pao Chiao Rd New Taipei City, TW 231
Registration status	Active · expires 2026
Parent company	Unimax Medical Systems Inc. (owner-operator 10028682)
Brand names	Wound Retractor

Activity by year

Recalls (1)

Devices registered here (1)

Ring (Wound Protector), Drape Retention, Internal
Product code KGW (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

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

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 3007791595) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007791595-unimax-medical-systems-inc/

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