Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Recalled by Fisher & Paykel Healthcare, Ltd. Due to Fisher and Paykel Healthcare is recalling the ICON...
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
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
Quantity: 1,407 units
Why Was This Recalled?
Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
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