Withings® WPM05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700546705984), received between Feb 26, 2020 and Jan 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Readings” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023High Readings

  I HAD BEEN USING A WITHINGS BPM CONNECT BLOOD PRESSURE CUFF. IT WAS READING HIGH WHICH WE DID NOT REALIZE UNTIL I COMPARED IT WITH THE DOCTOR'S OFFICE BLOOD PRESSURE READING. THIS RESULTED IN ME TAKING A BLOOD PRESSURE MEDICATION FOR SEVERAL MONTHS WHEN I DID NOT REQUIRE ONE. OTHER THAN TAKING A MEDICATION I DIDN'T NEED, NO INJURY WAS SUSTAINED. I REPORTED TO WITHINGS AND HAVE HAD SEVERAL EMAILS BACK AND FORTH WITHOUT A SATISFACTORY RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225616 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings

  I PURCHASED THE WITHINGS BPM (BLOOD PRESSURE MONITOR) CONNECT BLOOD PRESSURE MONITOR ON (B)(6) 2022. IT READ THAT I HAD HIGH BLOOD PRESSURE FAIRLY CONSISTENTLY. I SAW MY DOCTOR ON (B)(6) 2022. I BROUGHT THE DEVICE. THEY CONFIRMED THAT I DID NOT HAVE BLOOD HIGH BLOOD PRESSURE. AFTER TAKING MULTIPLE READINGS WITH THE DEVICE AND WITH THE DOCTORS OFFICE EQUIPMENT THE DEVICE WAS CONSISTENTLY AROUND 30 POINT HIGH ON SYSTOLIC. I ENGAGED WITHINGS SUPPORT. THEY HAVE BEEN UNHELPFUL, REQUESTING THAT I FOLLOW DIRECTIONS, DOUBLE CHECK MY ARM CIRCUMFERENCE IS IN THE RANGE, GET READINGS FROM OTHER PEOPLE (WHICH ALSO SEEMED INACCURATE BUT WE HAD NO DEVICE TO COMPARE TO), AND IS NOW ASKING FOR VIDEOS OF ME TAKING THE BLOOD PRESSURE. THE DEVICE IS INACCURATE. LOOKING AT ONLINE REVIEWS THIS SEEMS TO BE A PROBLEM FOR AROUND 10% OF REVIEWERS. THIS CAUSES A BURDEN ON CONSUMERS TO SEE THEIR DOCTOR WHEN UNNECESSARY OR EVEN POSSIBLY CAUSING OVER MEDICATION IF THEY ARE TRYING TO MONITOR A KNOWN PROBLEM. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825688 ↗
• MalfunctionFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER STATED, "THE BLOOD PRESSURE READINGS COMPARED WITH THE READINGS AT MY CARDIOLOGIST ARE 20% OFF". WE RECEIVED ONLY THIS INFORMATION AND HAVE NO WAY FOR COMMUNICATING TO GET MORE ELSE. WE CAN ONLY SUPPOSE THAT THE USER IS COMPLAINING THIS BPM'S MEASUREMENT IS NOT ACCURACY.

  Patient problems: Test Result

  MAUDE report 9754122 ↗