Facility

Mercury Medical Enterprises, LLC

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

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)	1024404
Establishment type	Manufacture Medical Device
Location	11300 49th St N CLEARWATER, FL, US 33762
Registration status	Active · expires 2026
Parent company	Mercury Medical Enterprises, LLC (owner-operator 1024404)
Brand names	MASK, OXYGEN, NON-REBREATHING

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Mask, Oxygen, Non-Rebreathing
Product code KGB (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5570

Recalls & enforcement

Class IOngoing2024-12-10
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation …
Class IOngoing2024-08-30
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Class IITerminated2015-10-22
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

FDA inspections (1)

VAI2025-12-11
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.

All facilities operated by Mercury Medical Enterprises, LLC

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. “Mercury Medical Enterprises, LLC (FEI 1024404) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1024404-mercury-medical-enterprises-llc/

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