FEI 1024404Initial importer

Mercury Medical

11300 49th St N, CLEARWATER, FL, US

MDR events155All time

Recalls3All time

Registered products21

Establishment typeManufactureManufacture Medical Device

Registered product codes

21 product codes

Recent MDR events

155 on file

Recalls

3 on file

Open, ClassifiedJan 10, 2025
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 of the patient.
View FDA record ↗
Open, ClassifiedOct 2, 2024
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
View FDA record ↗
TerminatedUnknown
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
View FDA record ↗

Compliance history

Matched by FEI 1024404.

FDA inspections

2 on file

Voluntary Action Indicated (VAI)Dec 11, 2025
Compliance: Devices · Citations posted
No Action Indicated (NAI)Dec 11, 2025
Postmarket Assurance: Devices · Citations posted

Inspection citations

2 on file

Top cited requirements

Compare to industry ↗

21 CFR 820.80(b)Dec 11, 2025
Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Dec 11, 2025
Lack of or inadequate procedures

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.