FDA Medical devices recall ·
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0821-2025
- Date
- (initiated December 10, 2024)
- Company / brand
- Mercury Medical
11300 49th St N, Clearwater, FL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 37370
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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
States: Alaska Alabama Arkansas Arizona California Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0821-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.