ModerateClass IITerminated

FDA Devices recall · Reported June 5, 2013

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1437-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1437-2013) 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.

Q: 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.

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 inoper…

Recall #: Z-1437-2013
Affected scope: 1,407 units
Initiated: April 22, 2013

Compiled from official public sources by the editorial team. · Updated July 2026

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Fisher & Paykel Healthcare, Ltd. recalled Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: … - a moderate-severity action.

Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: … was recalled by Fisher & Paykel Healthcare, Ltd. in June 5, 2013. Reason: Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on cer…. Check the official notice for the remedy. Verify recall #Z-1437-2013 with the FDA Devices before acting.

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The recall

Fisher & Paykel Healthcare, Ltd. issued this moderate-severity FDA Devices recall-Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on cer….

Moderate
severity level: 1K units
affected scope: Class II
classification: June 5, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1437-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1437-2013) was formally reported on June 5, 2013, with the manufacturer initiating the action on April 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Fisher & Paykel Healthcare, Ltd. is listed as the recalling firm, operating out of North Shore City, N/A. Federal records list the affected scope as 1,407 units.

The documented reason for this recall is: 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 tr… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

1,407 units

Related Recalls

3 from same agency

Product description

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.

Reason for recall

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1437-2013
Date reported	June 5, 2013
Date initiated	April 22, 2013
Recalling firm	Fisher & Paykel Healthcare, Ltd.
Firm location	North Shore City, N/A
Affected scope	1,407 units
Distribution	Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1,407 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1437-2013) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1437-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1437-2013) 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 June 5, 2013. 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.