Clearwater, FL, United States
Mercury Enterprises, Inc. dba Mercury Medical recalls
2 recalls recorded since 2018, most recently on 10 December 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 10 December 2024
- 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.
- 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, Cana
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0821-2025
- Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Ongoing Class I Medical devices
- Recall started
- 30 August 2024
- Reason
- Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
- Distribution
- US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0004-2025
- Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.