FDA Medical Device Recalls (openFDA)
Mercury Enterprises, Inc. dba Mercury Medical: Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
- Recall number
- Z-0004-2025
- Recalling firm
- Mercury Enterprises, Inc. dba Mercury Medical
- Product
- Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
- Status
- Open, Classified
- Initiated
- 2024-08-30
- Posted
- 2024-10-02
- Terminated
- not on file
- Reason
- Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
- 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
- 1,300 units
- Distribution
- US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
- Lot, serial or model codes
- Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
- 510(k) numbers
- ["K093913"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 1024404
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28