# FDA recall Z-2133-2019

> **Xhale Assurance, Inc.** · Class II · device recall initiated 2019-05-08.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-2133-2019
- **Recalling firm:** Xhale Assurance, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-08
- **Report date:** 2019-08-07
- **Termination date:** 2022-04-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2019

## Citation

> AI Analytics. FDA recall Z-2133-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2133-2019. Source: US FDA. Licensed CC0.

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