Class II
Medical Device Recall: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
MEDLINE INDUSTRIES, LP - Northfield · August 30, 2024
Reason for Recall
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
States Affected
NATIONWIDE
Quantity Affected
9.608 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0033-2025
Status: ongoing
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