Omron 5 Series Connected Upper Arm Blood Pressure Monitor BP7250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00073796267254), received between Feb 18, 2021 and Apr 6, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Readings” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2023High Readings; High Readings

  THE CONSUMER STATED HER UNIT HAD BEEN READING HIGH AT THE DOCTOR'S OFFICE. HER UNIT READ 168/92-96 AND HER DOCTOR'S UNIT READ 130/60. SHE HAS BOUGHT SEVERAL OMRON UNITS AND KEEPS BUYING THEM. SHE WENT TO THE OMRON WEBSITE TO SEE IF SHE COULD CALIBRATE THE UNIT. SHE WAS THE ONLY USER. SHE USED THE UNIT THREE TIMES A DAY. SHE USED HER LEFT ARM WITH THE CUFF RIGHT ABOVE HER ELBOW BEND AND THE AIR HOSE WENT TO THE SIDE OF HER ARM. SHE WOULD TAKE A READING ON HER BED WITH HER LEGS STRAIGHT OUT OR ON HER LIVING ROOM CHAIR WITH HER FEET FLAT ON THE FLOOR. SHE WOULD NOT TALK OR MOVE DURING THE READING. SHE STATED THAT HER CUFF WAS THE CORRECT SIZE FOR HER ARM. SHE STATED SHE HAD A STROKE THE WEEK OF (B)(6) 2023. DURING A FOLLOW-UP, SHE STATED SHE DOES NOT HAVE ANY FAMILY. SHE STATED HER OMRON UNITS KEEP BREAKING DOWN SO SHE BUYS ANOTHER ONE. SHE STATED SHE BOUGHT THIS UNIT IN 2022. WHEN HER DOCTOR DID A MACHINE COMPARISON, HE WOULD TAKE THE READINGS SIMULTANEOUSLY ON EACH ARM WITH HIS UNIT ON HER RIGHT ARM AND THE OMRON UNIT ON HER LEFT ARM. THEY HAD ALSO DONE COMPARISON READINGS ON THE SAME ARM, WAITING 2-4 MINUTES IN BETWEEN. SHE TOOK HER READINGS 3 TIMES A DAY AND USED THE ORIGINAL CUFF

  Patient problems: Stroke/CVA

  MAUDE report 16697305 ↗
• InjuryApr 3, 2023High Readings; High Readings

  THE CONSUMER STATED HER UNIT HAD BEEN READING HIGH AT THE DOCTOR'S OFFICE. HER UNIT READ 168/92-96 AND HER DOCTOR'S UNIT READ 130/60. SHE HAS BOUGHT SEVERAL OMRON UNITS AND KEEPS BUYING THEM. SHE WENT TO THE OMRON WEBSITE TO SEE IF SHE COULD CALIBRATE THE UNIT. SHE WAS THE ONLY USER. SHE USED THE UNIT THREE TIMES A DAY. SHE USED HER LEFT ARM WITH THE CUFF RIGHT ABOVE HER ELBOW BEND AND THE AIR HOSE WENT TO THE SIDE OF HER ARM. SHE WOULD TAKE A READING ON HER BED WITH HER LEGS STRAIGHT OUT OR ON HER LIVING ROOM CHAIR WITH HER FEET FLAT ON THE FLOOR. SHE WOULD NOT TALK OR MOVE DURING THE READING. SHE STATED THAT HER CUFF WAS THE CORRECT SIZE FOR HER ARM. SHE STATED SHE HAD A STROKE THE WEEK OF (B)(6) 2023. DURING A FOLLOW-UP, SHE STATED SHE DOES NOT HAVE ANY FAMILY. SHE STATED HER OMRON UNITS KEEP BREAKING DOWN SO SHE BUYS ANOTHER ONE. SHE STATED SHE BOUGHT THIS UNIT IN 2022. WHEN HER DOCTOR DID A MACHINE COMPARISON, HE WOULD TAKE THE READINGS SIMULTANEOUSLY ON EACH ARM WITH HIS UNIT ON HER RIGHT ARM AND THE OMRON UNIT ON HER LEFT ARM. THEY HAD ALSO DONE COMPARISON READINGS ON THE SAME ARM, WAITING 2-4 MINUTES IN BETWEEN. SHE TOOK HER READINGS 3 TIMES A DAY AND USED THE ORIGINAL CUFF

  Patient problems: Stroke/CVA

  MAUDE report 16665913 ↗
• InjuryOct 6, 2022Inflation Problem; Inflation Problem

  THE CONSUMER STATED THAT, AFTER SHE PURCHASED THE UNIT, SHE USED THE MONITOR ONCE OR TWICE A WEEK EXCEPT DURING THE MONTH OF MAY. SHE STATED SHE HATED THE UNIT BECAUSE IT SQUEEZED TOO TIGHTLY TO THE POINT HER LEFT ARM WAS NEARLY FAINTING. SHE STATED IT WAS PAINFUL AND THAT HER ARM FELT LIKE IT WAS BEING WRAPPED AROUND BY A BOA CONSTRICTOR TYPE OF SNAKE. SHE NOTICED A RHYTHM OF HER HEART GOING "LUB-DUB" COMING FROM HER INNER ARM CUFF SEVERAL SECONDS BEFORE THE SQUEEZE WAS OVER. SHE FELT RELIEVED WHEN IT WAS DONE. SHE HAD NEVER HAD ANY INJURY TO HER ARMS IN HER LIFE. ON (B)(6) 2022, HER FIRST MEASUREMENT WAS TIGHT AS USUAL SO SHE SHUT OFF THE UNIT AND CHECKED FOR ITS POSITION AND SNUGNESS. SHE GAVE HERSELF A BREAK BEFORE TAKING ANOTHER MEASUREMENT. THE FOLLOWING MORNING, SHE WAS CHANGING HER CLOTHING WHEN SHE NOTICED A PAIN IN HER LEFT ARM BETWEEN HER WRIST AND ELBOW. THE AREA WAS WARM TO THE TOUCH AND THE MUSCLE WAS HARD LIKE IT WAS PUMPED UP. SHE ICED HER ARM, BUT IT DID NOT HELP; THERE WAS NO IMPROVEMENT. HER ARM WAS STILL PAINFUL AND WARM AND THE AREA WAS STILL HARD WHILE SHE WAS LYING IN BED. SHE BELIEVED HER OMRON BLOOD PRESSURE MONITOR WAS THE CAUSE. SHE STATED THE UNIT INFLAT

  Patient problems: Loss of Range of Motion; Myalgia; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15549039 ↗
• InjurySep 30, 2022Inflation Problem; Inflation Problem

  THE CONSUMER STATED THAT, AFTER SHE PURCHASED THE UNIT, SHE USED THE MONITOR ONCE OR TWICE A WEEK EXCEPT DURING THE MONTH OF MAY. SHE STATED SHE HATED THE UNIT BECAUSE IT SQUEEZED TOO TIGHTLY TO THE POINT HER LEFT ARM WAS NEARLY FAINTING. SHE STATED IT WAS PAINFUL AND THAT HER ARM FELT LIKE IT WAS BEING WRAPPED AROUND BY A BOA CONSTRICTOR TYPE OF SNAKE. SHE NOTICED A RHYTHM OF HER HEART GOING "LUB-DUB" COMING FROM HER INNER ARM CUFF SEVERAL SECONDS BEFORE THE SQUEEZE WAS OVER. SHE FELT RELIEVED WHEN IT WAS DONE. SHE HAD NEVER HAD ANY INJURY TO HER ARMS IN HER LIFE. ON 9/12/22, HER FIRST MEASUREMENT WAS TIGHT AS USUAL SO SHE SHUT OFF THE UNIT AND CHECKED FOR ITS POSITION AND SNUGNESS. SHE GAVE HERSELF A BREAK BEFORE TAKING ANOTHER MEASUREMENT. THE FOLLOWING MORNING, SHE WAS CHANGING HER CLOTHING WHEN SHE NOTICED A PAIN IN HER LEFT ARM BETWEEN HER WRIST AND ELBOW. THE AREA WAS WARM TO THE TOUCH AND THE MUSCLE WAS HARD LIKE IT WAS PUMPED UP. SHE ICED HER ARM, BUT IT DID NOT HELP; THERE WAS NO IMPROVEMENT. HER ARM WAS STILL PAINFUL AND WARM AND THE AREA WAS STILL HARD WHILE SHE WAS LYING IN BED. SHE BELIEVED HER OMRON BLOOD PRESSURE MONITOR WAS THE CAUSE. SHE STATED THE UNIT INFLATED L

  Patient problems: Loss of Range of Motion; Myalgia; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15513845 ↗
• MalfunctionMay 26, 2022Fire; Overheating of Device; Fire; Overheating of Device

  THE CONSUMER WAS INQUIRING ON PURCHASING A NEW AC ADAPTER FOR HER BP7250 UNIT. SHE STATED THE AC ADAPTER CAUGHT FIRE BUT NO ONE WAS HURT. SHE WAS ADVISED TO MAKE SURE TO PROPERLY DISPOSE OF THE ADAPTER. SHE STATED SHE WILL NOT ACCEPT CALLS SO THE SUPERVISOR WILL NEED TO EMAIL HER TO FOLLOW-UP. OMRON CUSTOMER SERVICE REPRESENTATIVE SENT MULTIPLE EMAILS REQUESTING ADDITIONAL DETAILS. THE CONSUMER HAS NOT ANSWERED ANY EMAILS TO FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14506023 ↗
• MalfunctionMay 24, 2022Fire; Overheating of Device; Fire; Overheating of Device

  THE CONSUMER WAS INQUIRING ON PURCHASING A NEW AC ADAPTER FOR HER BP7250 UNIT. SHE STATED THE AC ADAPTER CAUGHT FIRE BUT NO ONE WAS HURT. SHE WAS ADVISED TO MAKE SURE TO PROPERLY DISPOSE OF THE ADAPTER. SHE STATED SHE WILL NOT ACCEPT CALLS SO THE SUPERVISOR WILL NEED TO EMAIL HER TO FOLLOW-UP. OMRON CUSTOMER SERVICE REPRESENTATIVE SENT MULTIPLE EMAILS REQUESTING ADDITIONAL DETAILS. THE CONSUMER HAS NOT ANSWERED ANY EMAILS TO FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487095 ↗
• InjuryFeb 1, 2022High Readings; High Readings

  THE CONSUMER REPORTED SHE RECEIVED AN OMRON UPPER ARM BLOOD PRESSURE MONITOR, BP7250, AS A GIFT. THE UNIT WAS RECOMMENDED BY HER DOCTOR. AFTER MONITORING HER BLOOD PRESSURE FOR AWHILE, SHE SENT THE RESULTS TO HER DOCTOR. SINCE THEY WERE EXTREMELY HIGH READINGS, HER DOCTOR DECIDED TO CHANGE AND ADJUST HER BLOOD PRESSURE MEDICATIONS. THE CONSUMER STATED THAT THIS CHANGE IN MEDICATION RESULTED IN HER COLLAPSING AND SPENDING 4 DAYS IN THE HOSPITAL TO CONTROL HER BLOOD PRESSURE. SHE MET WITH HER DOCTOR ON 2 DIFFERENT OCCASIONS AFTER THIS. SHE BROUGHT IN HER OMRON MONITOR AND COMPARED THE READINGS WITH HER DOCTOR'S MONITOR. HER DOCTOR TOOK A READING TWICE WITH HIS UNIT RESULTS AVERAGING 130/70 AND THE OMRON DEVICE AVERAGING 180/93. MULTIPLE ATTEMPTS WERE MADE BY OMRON TO CONTACT THE CONSUMER FOR ADDITIONAL INFORMATION, BUT THE CONSUMER DID NOT ANSWER. FOLLOW-UP CALLS WERE MADE ON 1/17/22, 1/18/22, 1/19/22, 1/21/22, 1/24/22, AND 1/27/22.

  Patient problems: Syncope/Fainting

  MAUDE report 13408755 ↗
• InjuryJan 28, 2022High Readings; High Readings

  THE CONSUMER REPORTED SHE RECEIVED AN OMRON UPPER ARM BLOOD PRESSURE MONITOR, BP7250, AS A GIFT. THE UNIT WAS RECOMMENDED BY HER DOCTOR. AFTER MONITORING HER BLOOD PRESSURE FOR AWHILE, SHE SENT THE RESULTS TO HER DOCTOR. SINCE THEY WERE EXTREMELY HIGH READINGS, HER DOCTOR DECIDED TO CHANGE AND ADJUST HER BLOOD PRESSURE MEDICATIONS. THE CONSUMER STATED THAT THIS CHANGE IN MEDICATION RESULTED IN HER COLLAPSING AND SPENDING 4 DAYS IN THE HOSPITAL TO CONTROL HER BLOOD PRESSURE. SHE MET WITH HER DOCTOR ON 2 DIFFERENT OCCASIONS AFTER THIS. SHE BROUGHT IN HER OMRON MONITOR AND COMPARED THE READINGS WITH HER DOCTOR'S MONITOR. HER DOCTOR TOOK A READING TWICE WITH HIS UNIT RESULTS AVERAGING 130/70 AND THE OMRON DEVICE AVERAGING 180/93. MULTIPLE ATTEMPTS WERE MADE BY OMRON TO CONTACT THE CONSUMER FOR ADDITIONAL INFORMATION, BUT THE CONSUMER DID NOT ANSWER. FOLLOW-UP CALLS WERE MADE ON 1/17/2022, 1/18/2022, 1/19/2022, 1/21/2022, 1/24/2022, AND 1/27/2022

  Patient problems: Syncope/Fainting

  MAUDE report 13387935 ↗
• InjuryFeb 22, 2021High Readings; High Readings

  CONSUMER REPORTED THE UNIT IS READING HIGH AT HOME SO DID A COMPARISON AT DOCTOR'S OFFICE AND IT READ CLOSE TO 25 MMHG HIGHER. AT THE DOCTOR'S OFFICE MANUAL BP READING WAS DONE 1ST ON HIS RIGHT ARM; 108/70, THEN ON HIS HOME UNIT; 132/87 AND AFTER THAT READING WAS TAKEN ON HIS OLD OMRON UNIT; 132/92. CONSUMER WAS ADVISED TO ALLOW ENOUGH TIME IN BETWEEN READINGS FOR ARTERIES TO DECOMPRESS. CUSTOMER SERVICE REPRESENTATIVE PROVIDED PROPER INSTRUCTIONS FOR CUFF APPLICATION. CONSUMER INDICATED HIGH READINGS AT HOME AND HE SITES AT THE KITCHEN TABLE AND FOLLOWS THE DIRECTIONS. CONSUMER WAS INFORMED THAT IF THE UNIT IS RETUNED FOR INSPECTION AND IF IT PASSES INSPECTION, IT WILL RETURNED BACK TO HIM. CONSUMER GOT UPSET AND STATED HE WENT TO THE DOCTOR A FEW WEEKS AGO BECAUSE OF THE HIGH READINGS. HE HAD MORE TEST DONE. HE HAD CT SCAN DONE. CUSTOMER SERVICE REPRESENTATIVE ADVISED CONSUMER NOT USE THE UNIT AGAIN AND SENT A PRE-PAID SHIPPING LABEL TO RETRIEVE THE UNIT FOR FURTHER TESTING. CONSUMER REPORTED HAD DYE INJECTED DURING THE SCAN AND FOUND OUT THE DYE CAUSES KIDNEY ISSUES AND HE IS NOW IN STAGE 3 KIDNEY FAILURE. HE DOES HAVE HEART ISSUES. CONSUMER NORMAL BP RANGE FOR HIM IS 108/70 AND

  Patient problems: Renal Impairment

  MAUDE report 11356928 ↗
• InjuryFeb 18, 2021High Readings; High Readings

  CONSUMER REPORTED THE UNIT IS READING HIGH AT HOME SO DID A COMPARISON AT DOCTOR'S OFFICE AND IT READ CLOSE TO 25 MMHG HIGHER. AT THE DOCTOR'S OFFICE MANUAL BP READING WAS DONE 1ST ON HIS RIGHT ARM; 108/70, THEN ON HIS HOME UNIT; 132/87 AND AFTER THAT READING WAS TAKEN ON HIS OLD OMRON UNIT; 132/92. CONSUMER WAS ADVISED TO ALLOW ENOUGH TIME IN BETWEEN READINGS FOR ARTERIES TO DECOMPRESS. CUSTOMER SERVICE REPRESENTATIVE PROVIDED PROPER INSTRUCTIONS FOR CUFF APPLICATION. CONSUMER INDICATED HIGH READINGS AT HOME AND HE SITES AT THE KITCHEN TABLE AND FOLLOWS THE DIRECTIONS. CONSUMER WAS INFORMED THAT IF THE UNIT IS RETUNED FOR INSPECTION AND IF IT PASSES INSPECTION, IT WILL RETURNED BACK TO HIM. CONSUMER GOT UPSET AND STATED HE WENT TO THE DOCTOR A FEW WEEKS AGO BECAUSE OF THE HIGH READINGS. HE HAD MORE TEST DONE. HE HAD CT SCAN DONE. CUSTOMER SERVICE REPRESENTATIVE ADVISED CONSUMER NOT USE THE UNIT AGAIN AND SENT A PRE-PAID SHIPPING LABEL TO RETRIEVE THE UNIT FOR FURTHER TESTING. CONSUMER REPORTED HAD DYE INJECTED DURING THE SCAN AND FOUND OUT THE DYE CAUSES KIDNEY ISSUES AND HE IS NOW IN STAGE 3 KIDNEY FAILURE. HE DOES HAVE HEART ISSUES. CONSUMER NORMAL BP RANGE FOR HIM IS 108/70 AND

  Patient problems: Renal Impairment

  MAUDE report 11346277 ↗