Fisher & Paykel Healthcare, Ltd.
Complete recall history across all FDA and CPSC categories — 7 total recalls
Fisher & Paykel Healthcare, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (7)
FDA medical device enforcement actions by Fisher & Paykel Healthcare, Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 18, 2025 | Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Ki... | When unintentionally disconnected from power source, humidifier device (used ... | Class II |
| Aug 7, 2024 | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/o... | Due to a software issue, affected devices that are set up with High Pressure ... | Class II |
| Apr 2, 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Humidifier devices, used to deliver high flow respiratory therapy to patients... | Class II |
| Nov 6, 2014 | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and P... | Breakage of the nut that secures the heater head in place, which can cause th... | Class II |
| Apr 15, 2014 | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... | The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing... | Class I |
| Apr 22, 2013 | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). ... | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there i... | Class II |
| Nov 19, 2012 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... | FPH has become aware that one batch of tubes supplied to FPH may contain hole... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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