Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 26, 2022
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The moni…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien, LP recalled SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. us… - a moderate-severity action.
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. us… was recalled by Covidien, LP in January 26, 2022. Reason: Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely d…. Check the official notice for the remedy. Verify recall #Z-0514-2022 with the FDA Devices before acting.
The recall
Covidien, LP issued this moderate-severity FDA Devices recall-Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely d….
- Moderate
- severity level
- 66 units
- affected scope
- Class II
- classification
- January 26, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0514-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0514-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on December 22, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien, LP is listed as the recalling firm, operating out of North Haven, CT. Federal records list the affected scope as 66 devices.
The documented reason for this recall is: Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable di… Distribution data in the federal record shows the product reached: The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.. 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
66 devices
Related Recalls
6
3 from same agency
Product description
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Reason for recall
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0514-2022 |
| Date reported | January 26, 2022 |
| Date initiated | December 22, 2021 |
| Recalling firm | Covidien, LP |
| Firm location | North Haven, CT |
| Affected scope | 66 devices |
| Distribution | The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX. |
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-0514-2022) 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? ▼
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT). Recalled by Covidien, LP. Units affected: 66 devices.
Why was this product recalled? ▼
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0514-2022.
Where was the recalled product distributed? ▼
Distribution: The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0514-2022) 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 January 26, 2022. 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.