FDA Medical Device Recalls (openFDA)
SonarMed Inc: AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Recall number
- Z-1521-2024
- Recalling firm
- SonarMed Inc
- Product
- AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Status
- Open, Classified
- Initiated
- 2024-03-21
- Posted
- 2024-04-18
- Terminated
- not on file
- Reason
- The failure to detect the partial obstruction in a 2.5mm sensor.
- Root cause
- Process control
- Action
- 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 rs.covidienfeedbackcustomerservice@medtronic.com. 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.
- Quantity
- 500 units
- Distribution
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K193058"]
- PMA numbers
- not on file
- Product code
- OQU
- Firm FEI
- 3009923584
- Firm city
- Carmel
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28