Facility

CARBON MEDICAL TECHNOLOGIES, INC.

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

Key facts

2recalls · 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)	3002619738
Establishment type	Manufacture Medical Device
Location	1290 HAMMOND RD STE 2 Saint Paul, MN, US 55110
Registration status	Active · expires 2026
Parent company	Carbon Medical Technologies, Inc. (owner-operator 9034784)
Brand names	Durasphere Injectable Bulking Agent

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (1)

Agent, Bulking, Injectable For Gastro-Urology Use
Product code LNM (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIIOngoing2024-07-26
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Class IITerminated2022-12-16
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.

FDA inspections (3)

NAI2023-11-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-12-16
No Action Indicated · Compliance: Devices
NAI2016-03-09
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 Carbon Medical Technologies, 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. “CARBON MEDICAL TECHNOLOGIES, INC. (FEI 3002619738) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002619738-carbon-medical-technologies-inc/

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