CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report

Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor recalled

Xhale Assurance is recalling Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, distributed nationwide in the US. The recall was initiated on 8 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Codes (Lot Numbers): 0303 (101619, 101624, 101628, 101632, 101637, 101642, 101646, 101647, 101651, 101701, 201651, 101707, 101715, XH101711, XH101720, XH101715, XH101726, XH101729, XH101733, XH101737, XH101820, XH101842), 301-11214 (TR101711, TR101715, TR101720, TR101726, TR101729, TR101744, TR101733, TR101737, TR101748, TR101742, TR101746, TR101750, TR101803, TR101811, TR101817, TR101820, TR101824, TR101829, TR101833, TR101838, TR101842, TR101847, TR101852), 0201-A01(PF101736, PF101806, PF101814, PF101817, PF101819, PF101822, PF101828, PF101833, PF101838). Instructions for Use for revisions 10412_7 and prior (i.e. 10412_6, 10412_5, etc) as well as 10358_6 and prior. Shelf life is 3 years for sensors manufactured prior to Oct 2018. 5 years for sensor manufactured on or after Oct 2018.

Quantity recalled701,272 devices total

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-2133-2019
FDA event ID: 82817
Recalling firm: Xhale Assurance, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 8 May 2019
FDA classified: 30 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

8 May 2019	Recall initiated by company
30 Jul 2019	Classified by FDA	+83 days
7 Aug 2019	Published in enforcement report	+8 days

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

Reason for recall

These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision

Where it was distributed

US Nationwide distribution to AZ, CA, FL, KS, LA, MA , MO, MS, NC, NY, OH, PA, TX, WI. International distribution to Canada, Germany, Malaysia, United Kingdom.

Nationwide Arizona California Florida Kansas Louisiana Massachusetts Missouri Mississippi North Carolina New York Ohio Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

Which lots are affected?

Reference Codes (Lot Numbers): 0303 (101619, 101624, 101628, 101632, 101637, 101642, 101646, 101647, 101651, 101701, 201651, 101707, 101715, XH101711, XH101720, XH101715, XH101726, XH101729, XH101733, XH101737, XH101820, XH101842), 301-11214 (TR101711, TR101715, TR101720, TR101726, TR101729, TR101744, TR101733, TR101737, TR101748, TR101742, TR101746, TR101750, TR101803, TR101811, TR101817, TR101820, TR101824, TR101829, TR101833, TR101838, TR101842, TR101847, TR101852), 0201-A01(PF101736, PF101806, PF101814, PF101817, PF101819, PF101822, PF101828, PF101833, PF101838). Instructions for Use for revisions 10412_7 and prior (i.e. 10412_6, 10412_5, etc) as well as 10358_6 and prior. Shelf life is 3 years for sensors manufactured prior to Oct 2018. 5 years for sensor manufactured on or after Oct 2018.

Where was it sold?

US Nationwide distribution to AZ, CA, FL, KS, LA, MA , MO, MS, NC, NY, OH, PA, TX, WI. International distribution to Canada, Germany, Malaysia, United Kingdom.

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.

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