Nasal Alar SpO2 Sensor — Class II medical device recall Z-2133-2019
Terminated recall by Xhale Assurance, Inc., reported 2019-08-07, distributed nationwide. These Instructions for Use has missing instructions related to the checking and changing of the application si
| Recall number | Z-2133-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xhale Assurance, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-05-08 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2022-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, GB, MY |
| Quantity | 701,272 devices |
| Lot numbers | 0303, 101624, 101628, 101632, 101637, 101642, 101646, 101647, 101651, 101701, 101707, 101715, 201651, 301-11214, PF101806, PF101814, PF101817, PF101819, PF101822, PF101828, PF101833, TR101715, TR101720, TR101726, TR101729, TR101733, TR101737, TR101742, TR101744, TR101746, TR101748, TR101750, TR101803, TR101811, TR101817, TR101820, TR101824, TR101829, TR101833, TR101838 and 10 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2133-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.