AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with… recallZ-1521-2024 · SonarMed Inc · initiated Mar 21, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SonarMed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The failure to detect the partial obstruction in a 2.5mm sensor.
FDA root cause category: Process control
What the company is doing
An Urgent Medical Device Recall notification dated 3/25/2024 was mailed to consignees via UPS notifying them of this SonarMed Sensor recall. Consignees were asked to discontinue use of affected devices, quarantine any affected devices, and return all quarantined devices to Medtronic by obtaining a Returned Goods Authorization (RGA) from [email protected]. If product was purchased through a distributor the distributor can arrange for return. The provided notification is to be provided to those within consignee organizations that need to be made aware and if product was further distributed. Consignees with questions are to contact customer service at 800-962-9888, Option 2.
Recall details
- Recall number
- Z-1521-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 21, 2024
- Posted by the FDA
- Apr 18, 2024
- Recalling firm
- SonarMed Inc
- Quantity
- 500 units
- Product code
- OQU
- FDA submissions
- K193058
- Distribution
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Product description
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Code information (models, lots, serial numbers)
Product Number/CFN: AW-S035; UDI-DI: 10851334007206; Serial Numbers: A20221012, A20221019, A20221026, A20221109, A20221110, A20221111, A20221114, A20221212, A20221213, A20221214, A20221215, A20221216, A20230110, A20230111, A20230112, A20230113, A20230116, A20230130, A20230131, A20230202, A20230206, A20230306, A20230307.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SonarMed AirWave AW-S035Sonarmed, Inc · Airway Monitoring System1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 94292).
- Z-1519-2024 · Open, ClassifiedAW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Z-1520-2024 · Open, ClassifiedAW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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