SonarMed recalls

SonarMed has 5 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 24 Apr 2024. 4 are still ongoing. The most frequent reason is device malfunction.

Total recalls5since 2019

Last 12 months0reported

Class I480% of total

Ongoing4latest 24 Apr 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 4 80%Class II 1 20%Class III 0 0%

Why sonarmed is recalled

Device Malfunction480%
Other Reasons120%

Product types

Patient Monitors5100%

By year

2024480%
2019120%

Ongoing sonarmed recalls

4 active

Reported	Class	Recall	Company	Reason	Where
24 Apr 2024Device	CLASS I	Aw-S030 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-S025 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-S035 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-m0001 Sonarmed Monitor recalled	SonarMed	Device Malfunction	19 states

All sonarmed recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
24 Apr 2024Device	CLASS I	Aw-S030 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-S025 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-S035 Neo Sonarmed Sensor Used in conjunction recalled	SonarMed	Device Malfunction	19 states
24 Apr 2024Device	CLASS I	Aw-m0001 Sonarmed Monitor recalled	SonarMed	Device Malfunction	19 states
11 Sep 2019Device	CLASS II	AirWave Monitor recalled by SonarMed	SonarMed	Other	CA, TX

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.