Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Infant Nasal CPAP (continuous positive airway pressure) Prong Recalled by Fisher & Paykel Healthcare, Ltd. Due to The Infant Nasal CPAP Prong has the potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fisher & Paykel Healthcare, Ltd. directly.
Affected Products
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
Quantity: 62,063 units total (14,420 units USA)
Why Was This Recalled?
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare, Ltd. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report