Masimo Corporation Radical Handheld Pulse Oximeter Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Radical Handheld Pulse Oximeter
Brand
Masimo Corporation
Lot Codes / Batch Numbers
Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
Products Sold
Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
Masimo Corporation is recalling Radical Handheld Pulse Oximeter due to Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
Recommended Action
Per FDA guidance
Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026