FDA approvals and recalls

Neonatal: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

1 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Beyfortus (nirsevimab)

    Approved for: BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV sea…

    BLA761328

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

120 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Attachment, Breathing, Positive End Expiratory Pressure

    Reason: Potential cracks in the hose, which could lead to leakage or the hose falling off.

    Z-3252-2026

  • Ventilator, Non-Continuous (Respirator)

    Reason: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiven…

    Z-3139-2026

  • Ventilator, Non-Continuous (Respirator)

    Reason: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiven…

    Z-3140-2026

  • Infant Supine Sleep System

    Reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

    Z-3175-2026

  • Infant Supine Sleep System

    Reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

    Z-3176-2026

  • Set, Tubing And Support, Ventilator (W Harness)

    Reason: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or o…

    Z-2992-2026

  • Humidifier Nebulizer Kit

    Reason: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or o…

    Z-2993-2026

  • Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

    Reason: Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

    Z-2713-2026

  • Ventilator, Emergency, Manual (Resuscitator)

    Reason: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, pote…

    Z-2357-2026

  • Warmer, Infant Radiant

    Reason: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, pote…

    Z-2358-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

12 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

3,829 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Seizure376 reports
  2. 2Irritability193 reports
  3. 3Somnolence143 reports
  4. 4Magnetic resonance imaging head abnormal128 reports
  5. 5Hospitalisation124 reports
  6. 6Infantile spasms116 reports
  7. 7Vomiting111 reports
  8. 8Pruritus92 reports
  9. 9Eczema90 reports
  10. 10Crying88 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on neonatal

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Market reports on neonatal

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