Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 2, 2024
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happ…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fisher & Paykel Healthcare, Ltd. recalled PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 T… - a moderate-severity action.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 T… was recalled by Fisher & Paykel Healthcare, Ltd. in October 2, 2024. Reason: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignm…. Check the official notice for the remedy. Verify recall #Z-3262-2024 with the FDA Devices before acting.
The recall
Fisher & Paykel Healthcare, Ltd. issued this moderate-severity FDA Devices recall-Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignm….
- Moderate
- severity level
- 944 units
- affected scope
- Class II
- classification
- October 2, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3262-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3262-2024) was formally reported on October 2, 2024, with the manufacturer initiating the action on August 7, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fisher & Paykel Healthcare, Ltd. is listed as the recalling firm, operating out of Auckland. Federal records list the affected scope as 944 units.
The documented reason for this recall is: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desa… Distribution data in the federal record shows the product reached: U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
944 units
Related Recalls
6
3 from same agency
Product description
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Reason for recall
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3262-2024 |
| Date reported | October 2, 2024 |
| Date initiated | August 7, 2024 |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Firm location | Auckland |
| Affected scope | 944 units |
| Distribution | U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3262-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.. Recalled by Fisher & Paykel Healthcare, Ltd.. Units affected: 944 units.
Why was this product recalled? ▼
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3262-2024.
Where was the recalled product distributed? ▼
Distribution: U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3262-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 2, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.