FDAFDA · Food and drugs·Recall number Z-0033-2025
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Published October 16, 2024 · Recall initiated: August 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
- Lot
- GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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