Xhale Assurance Nasal SpO2 Sensor Recall for Missing Instructions
Xhale Assurance is recalling 701,272 Nasal Alar SpO2 Sensors because the Instructions for Use are missing steps for checking and changing the application site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to missing documentation (Instructions for Use) without reported injuries or illnesses, fitting the criteria for a Low severity documentation issue.
Plain-English summary
Xhale Assurance, Inc. is recalling 701,272 Nasal Alar SpO2 Sensors, Adult/Pediatric SpO2 Sensors, due to a documentation defect. The Instructions for Use (IFU) for specific revisions are missing instructions related to the checking and changing of the application site procedure.
The affected devices are 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. The recall includes sensors distributed nationwide in the United States to Arizona, California, Florida, Kansas, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Texas, and Wisconsin, as well as internationally to Canada, Germany, Malaysia, and the United Kingdom.
Healthcare providers and consumers should stop using the affected sensors and contact Xhale Assurance, Inc. for further instructions. The recall covers specific lot numbers and IFU revisions 10412_7 and prior, as well as 10358_6 and prior.
The recalled product
- Product
- 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…
- Manufacturer
- Xhale Assurance, Inc.
- Category
- Medical Device — Pulse Oximetry
- Hazard
- Affected units
- 701,272
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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