Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 7, 2019
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, u
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Xhale Assurance, Inc. recalled Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assur… - a moderate-severity action.
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assur… was recalled by Xhale Assurance, Inc. in August 7, 2019. Reason: These Instructions for Use has missing instructions related to the checking and changing of the application s…. Check the official notice for the remedy. Verify recall #Z-2133-2019 with the FDA Devices before acting.
The recall
Xhale Assurance, Inc. issued this moderate-severity FDA Devices recall-These Instructions for Use has missing instructions related to the checking and changing of the application s….
- Moderate
- severity level
- 701K units
- affected scope
- Class II
- classification
- August 7, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2133-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2133-2019) was formally reported on August 7, 2019, with the manufacturer initiating the action on May 8, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Xhale Assurance, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 701,272 devices total, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. Distribution data in the federal record shows the product reached: 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.. 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
701,272 devices total
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2133-2019 |
| Date reported | August 7, 2019 |
| Date initiated | May 8, 2019 |
| Recalling firm | Xhale Assurance, Inc. |
| Firm location | Gainesville, FL |
| Affected scope | 701,272 devices total |
| Distribution | 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. |
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-2133-2019) 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? ▼
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. Recalled by Xhale Assurance, Inc.. Units affected: 701,272 devices total.
Why was this product recalled? ▼
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2133-2019.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2133-2019) 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 August 7, 2019. 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.