Medical device recalls Moderate risk

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT recalled over fire hazard

Recall date
August 30, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Recall number
Z-0032-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

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