Skip to content
Recall Observatory FDA recall evidence

Device product

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

Z-0032-2025

August 30, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95318
Status
Ongoing
Classification
Class II
Quantity
52,521 units
Official record key
device-enforcement:Z-0032-2025

Official wording

Reason: 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.

Code information: GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.