Facility

INTER-MED, INC.

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

Key facts

2recalls · worst Class II

2inspections · 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)	3000209941
Establishment type	Manufacture Medical Device
Location	2200 South St Racine, WI, US 53404
Registration status	Active · expires 2026
Parent company	INTER-MED, INC. (owner-operator 9025886)
Brand names	Endo Sealer Solvent

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Cleanser, Root Canal
Product code KJJ (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2026-05-27
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of…
Class IITerminated2019-06-27
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the blea…

FDA inspections (2)

NAI2016-08-19
No Action Indicated · Compliance: Devices
VAI2016-04-29
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. “INTER-MED, INC. (FEI 3000209941) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000209941-inter-med-inc/

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