Z-0821-2025Class I

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809...

Name: Z-0821-2025 Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809...
Creator: Mercury Enterprises, Inc. dba Mercury Medical
Published: 2024-12-10
License: https://open.fda.gov/license/

Mercury Medical Enterprises, LLC / initiated 2024-12-10 / Open, Classified / root cause: manufacturing process

FDA source

Mercury Enterprises, Inc. dba Mercury Medical began a recall of Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839... on 2024-12-10. FDA classified it as Class I and gives the reason as "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...". 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-0821-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-10
Posted: 2025-01-10
Recalling firm: Mercury Medical Enterprises, LLC
Product: Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 12/10/2024, "URGENT: FIELD SAFETY NOTICE" letters were mailed and emailed to medical facilities and distributors who were asked to do the following: Medical Facilities/Distributors: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Contact firm's customer service department at [email protected] (Domestic) and [email protected] (International) to assist you on how to send the affected product back to the firm for product replacement or credit. 3) Please notify all personnel subject to using these devices. 4) Complete and return the response form via email to [email protected] In addition, distributors were asked to do the following: 5) Provide a copy of this recall notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. If you have any questions regarding this action, contact the firm at 800-237-6418/727-573-0088, or e-mail at [email protected]
Quantity in commerce: 37370
Distribution: Worldwide Distribution: US (nationwide) to states of: PA, FL, IN, WI, ME, SC, WY, ID, MT, TX, MI, LA, MS, AR, WV, MD, KY, NJ, WA, CA, GA, MO, MA, NC, NV, TN, VA, OK, ND, MN, AL, HI, UT, NY, AZ, IL, OH, IA, NE, CT, AK, OR and OUS (foreign) to countries of: Hungary, Switzerland, Hong Kong, Spain, Canada, Italy, United Kingdom, United Arab Emirates, Saudi Arabia, France, Netherlands
Product codes and lots: Part/UDI-DI/Lot: 1050805/10641043508053, 30641043508057/2421450805, 2423550805, 2423650805, 2426750805; 1050808/10641043508084, 30641043508088/2426450808, 2426750808, 2426850808, 2429050808, 2429350808; 1050809/10641043508091, 30641043508095/2426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809; 1050810 /10641043508107, 30641043508101/2426750810, 2429350810, 2429750810, 2429850810, 2430250810; 1050811/10641043508114, 30641043508118/2426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811; 1050814/10641043508145, 30641043508149/2426450814, 2426750814, 2429050814, 2429750814, 2430250814; 1050832/10641043508329, 30641043508323/2429050832, 242985083; 1050839/10641043508398, 30641043508392/2430350839; 1050840/10641043508404, 30641043508408/2429050840, 2429750840; 1050841/10641043508411, 30641043508415/2429050841; 1050842/10641043508428, 30641043508422/2426750842

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0821-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0821-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

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)