CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

OxiMax N-65 Handheld Pulse Oximeter recalled

Covidien LP (formerly Nellcor Puritan Bennett Inc.) is recalling OxiMax N-65 Handheld Pulse Oximeter, distributed nationwide in the US. The recall was initiated on 29 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots of Product Code N650, N65, N65-1, N65P, N65P-1

Quantity recalled211,426 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2267-2015
FDA event ID: 71583
Recalling firm: Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2015
FDA classified: 27 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

29 Jun 2015	Recall initiated by company
27 Jul 2015	Classified by FDA	+28 days
5 Aug 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential missing segments on the display that can result in misinterpretation of data.

Product as listed by the FDA

OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

Where it was distributed

Worldwide Distribution - US Nationwide including Canada.

Nationwide

Questions about this recall

Why was it recalled?

Potential missing segments on the display that can result in misinterpretation of data.

Which lots are affected?

All Lots of Product Code N650, N65, N65-1, N65P, N65P-1

Where was it sold?

Worldwide Distribution - US Nationwide including Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 71583

This product is part of a recall event; the main page for the event is OxiMax N-560 Pulse Oximeter recalled by Covidien LP (formerly Nellcor.

Reported	Class	Recall	Company	Reason	Where
5 Aug 2015	CLASS II	OxiMax N-560 Pulse Oximeter recalled by Covidien LP (formerly Nellcor	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	Nationwide

More recalls from Covidien LP (formerly Nellcor Puritan Bennett Inc.)

All 7

Reported	Class	Recall	Company	Reason	Where
23 Mar 2016Device	CLASS II	Puritan Bennett 980 Ventilator System, PB980 Ventilator recalled	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	PR
26 Aug 2015Device	CLASS I	Puritan Bennett 980 Ventilator System, Universal recalled	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	Nationwide
5 Aug 2015Device	CLASS II	OxiMax N-560 Pulse Oximeter recalled by Covidien LP (formerly Nellcor	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	Nationwide
15 Jul 2015Device	CLASS I	Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy recalled	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	Nationwide
15 Jul 2015Device	CLASS I	Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy recalled	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	Other	Nationwide

Other Patient Monitors recalls

All 1,013

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide