Reported Apr 24, 2024 · Ongoing
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SonarMed Inc · 12220 N Meridian St Ste 150 · Carmel, IN · 46032-6972
Is this the product you have?
- AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Lot codes and dates
- Product Number/CFNAW-S025
- UDI-DI10851334007183
- Serial Numbers
A20221012A20221018A20221025A20221107A20221109A20221202A20221206A20221207A20221208A20221209A20230105A20230109A20230123A20230124A20230125A20230126A20230213A20230224A20230228A20230301A20230302A20230303A20230320A20230324A20230411A20230724A20230725
- Amount recalled
- 610 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
The failure to detect the partial obstruction in a 2.5mm sensor.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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