FDA recall Z-0033-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

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.

Key facts

Status
Ongoing
Initiation date
2024-08-30
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2025