Class I — Mercury Enterprises, Inc. dba Mercury Medical
| Recalling firm | Mercury Medical Enterprises, LLC |
|---|---|
| Registered facility | Mercury Medical Enterprises, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 |
| Quantity | 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 |
| Initiated | 2024-12-10 |
| Classified | 2025-01-10 |
| Recall number | Z-0821-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Mercury Enterprises, Inc. dba Mercury Medical (Z-0821-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95967/
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