Omron 7 Series Wrist Blood Pressure Monitor BP6350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00073796266356), received between May 24, 2022 and May 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Fire; Overheating of Device; Fire; Overheating of Device

  THE CONSUMER STATED HER WRIST UNIT CAUGHT FIRE ON ITS OWN. IT WAS SITTING ON THE TABLE WHEN IT CAUGHT FIRE. THE FIRE HAD DAMAGED A FEW THINGS ON HER TABLE, INCLUDING A CRYSTAL BOWL AND CUP HOLDER. SHE WAS WORRIED ABOUT THE FACT THAT SHE COULD HAVE BEEN WEARING THE UNIT WHEN THE FIRE HAPPENED. IT WAS REQUESTED THAT SHE SEND PICTURES OF THE DAMAGE. DURING A FOLLOW-UP CALL, SHE STATED SHE DID NOT KNOW HOW THE FIRE STARTED. IT STARTED WHILE THE UNIT WAS ON TOP OF THE TABLE AFTER SHE WENT INTO ANOTHER ROOM TO FIND A LIGHTER. SHE STATED THE UNIT CAUGHT FIRE NEXT TO A CRYSTAL SUGAR BOWL THAT HAD AN UNLIT CANDLE IN IT, AND THE BOWL HANDLE CAME OFF DUE TO THE FIRE. SHE STATED THERE WAS ALSO A BURN IN THE MIDDLE OF THE MAHOGANY TABLE, AND A SPRAY BOTTLE, CUP, AND PEWTER STATUE OF A FAIRY HOLDING A CRYSTAL BALL WERE ALSO DAMAGED. SHE WAS ABLE TO PUT THE FIRE OUT BY POURING WATER ON THE FIRE TWICE. HER SON'S GIRLFRIEND WAS A WITNESS TO THE FIRE. SHE STATED THE COST OF DAMAGE WAS ABOUT (B)(6) FOR THE STATUE AND (B)(6) FOR THE TABLE. SHE WOULD USE THE UNIT THREE TIMES A DAY AND HAD OWNED IT FOR ABOUT A MONTH. SHE WAS USING THE MAXELL BATTERIES THAT CAME WITH THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14505965 ↗
• MalfunctionMay 24, 2022Fire; Overheating of Device; Fire; Overheating of Device

  THE CONSUMER STATED HER WRIST UNIT CAUGHT FIRE ON ITS OWN. IT WAS SITTING ON THE TABLE WHEN IT CAUGHT FIRE. THE FIRE HAD DAMAGED A FEW THINGS ON HER TABLE, INCLUDING A CRYSTAL BOWL AND CUP HOLDER. SHE WAS WORRIED ABOUT THE FACT THAT SHE COULD HAVE BEEN WEARING THE UNIT WHEN THE FIRE HAPPENED. IT WAS REQUESTED THAT SHE SEND PICTURES OF THE DAMAGE. DURING A FOLLOW-UP CALL, SHE STATED SHE DID NOT KNOW HOW THE FIRE STARTED. IT STARTED WHILE THE UNIT WAS ON TOP OF THE TABLE AFTER SHE WENT INTO ANOTHER ROOM TO FIND A LIGHTER. SHE STATED THE UNIT CAUGHT FIRE NEXT TO A CRYSTAL SUGAR BOWL THAT HAD AN UNLIT CANDLE IN IT, AND THE BOWL HANDLE CAME OFF DUE TO THE FIRE. SHE STATED THERE WAS ALSO A BURN IN THE MIDDLE OF THE MAHOGANY TABLE, AND A SPRAY BOTTLE, CUP, AND PEWTER STATUE OF A FAIRY HOLDING A CRYSTAL BALL WERE ALSO DAMAGED. SHE WAS ABLE TO PUT THE FIRE OUT BY POURING WATER ON THE FIRE TWICE. HER SON'S GIRLFRIEND WAS A WITNESS TO THE FIRE. SHE STATED THE COST OF DAMAGE WAS ABOUT (B)(6) FOR THE STATUE AND (B)(6) FOR THE TABLE. SHE WOULD USE THE UNIT THREE TIMES A DAY AND HAD OWNED IT FOR ABOUT A MONTH. SHE WAS USING THE MAXELL BATTERIES THAT CAME WITH THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14486879 ↗