Xhale recalls adult/pediatric SpO2 sensors with missing instructions for checking and changing the application site. This affects specific lot numbers and models sold from 2018 onward.
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Xhale is recalling nasal SpO2 sensors that have missing instructions for checking and changing the application site. This could lead to improper use if users don't follow the correct procedures.
The sensors have missing instructions for checking and changing the application site, which could lead to improper use. This might cause inaccurate oxygen readings or discomfort if users don't follow the correct procedures.
Patients using the Xhale Nasal Alar SpO2 Sensor for oxygen monitoring may be affected, particularly those with medical conditions requiring continuous monitoring. Healthcare providers using these sensors are also at risk if they rely on outdated instructions.
Check the product label for lot numbers starting with 0303, 301-11214, or 0201-A01. These sensors were sold from 2018 onward with specific reference codes.
Look for lot numbers such as 0303, 301-11214, or 0201-A01 on the sensor packaging.
The recall is due to missing instructions for checking and changing the application site, which could lead to improper use.
The affected models include sensors with lot numbers starting with 0303, 301-11214, or 0201-A01, sold from 2018 onward.
No, but you should check the product label for the lot number to confirm if it's affected. The hazard is low risk as it involves missing instructions rather than immediate safety risks.
We’ve drafted a message you can send Xhale to request your refund or repair — edit it as you like.
Subject: Recall Z-2133-2019 — Xhale Xhale Hello, I own a Xhale that is covered by recall Z-2133-2019 from Xhale. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
