Facility

TORAX MEDICAL, INC.

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

Key facts

1recalls · worst Class II

3inspections · worst NAI

—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)	3008766073
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	4545 Creek Road Cincinnati, OH, US 45242
Registration status	Active · expires 2026
Parent company	Torax Medical Inc. (owner-operator 10040266)
Brand names	ETHICON LINX® Esophagus Sizing Tool

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Laparoscopic Accessories, Esophageal Sizing
Product code QJN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5360

Recalls & enforcement

Class IITerminated2018-04-20
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

FDA inspections (3)

NAI2023-11-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2020-02-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-11-08
No Action Indicated · Compliance: Devices

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.

All facilities operated by Torax 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. “TORAX MEDICAL, INC. (FEI 3008766073) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008766073-torax-medical-inc/

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