Mercury Enterprises, Inc. dba Mercury Medical: Device Recall

Recall #Z-0004-2025 · 08/30/2024

Class I: Dangerous

Recall Details

Recall Number: Z-0004-2025
Classification: Class I
Product Type: Device
Recalling Firm: Mercury Enterprises, Inc. dba Mercury Medical
Status: Ongoing
Date Initiated: 08/30/2024
Location: Clearwater, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,300 units

Reason for Recall

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

Product Description

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Distribution Pattern

US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

Other Recalls by Mercury Enterprises, Inc. dba Mercury Medical

Class I: Dangerous 12/10/2024

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 all recalls by Mercury Enterprises, Inc. dba Mercury Medical →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.