FDA Device Recall Z-0004-2025

Mercury Enterprises, Inc. dba Mercury Medical · Clearwater, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

Quantity: 1,300 units

Reason for recall

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

Recall record

Recall number: Z-0004-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Recall initiated: 2024-08-30
Classified by FDA Center: 2024-10-02
FDA published: 2024-10-09
Recalling firm: Mercury Enterprises, Inc. dba Mercury Medical
Firm location: Clearwater, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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