Z-0004-2025Class I

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

Name: Z-0004-2025 Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support
Creator: Mercury Enterprises, Inc. dba Mercury Medical
Published: 2024-08-30
License: https://open.fda.gov/license/

Mercury Medical Enterprises, LLC / initiated 2024-08-30 / Open, Classified / root cause: manufacturing process

FDA source

Mercury Enterprises, Inc. dba Mercury Medical began a recall of Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support on 2024-08-30. FDA classified it as Class I and gives the reason as "Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0004-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-02
Recalling firm: Mercury Medical Enterprises, LLC
Product: Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Mercury Medical notified customers on 09/04/2024 via letter. Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form. Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.
Quantity in commerce: 1,300 units
Distribution: US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Product codes and lots: Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0004-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-10-02

Product code BTL

K093913Class IIMercury Medical T-Piece ResuscitatorMercury Medical, Inc. / cleared 2010-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)