Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
Brand
Respironics, Inc.
Lot Codes / Batch Numbers
Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
Products Sold
Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
Respironics, Inc. is recalling NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 due to Gas input pressures over 62 psi may cause CPAP pressure oscillation. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Gas input pressures over 62 psi may cause CPAP pressure oscillation
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, GA, IL, IN, IA, MD, MA, MN, MO, NE, NH, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, PR
Page updated: Jan 10, 2026