Z-0033-2025 Class II Ongoing
FDA device recall Z-0033-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Aug 30, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 9.608 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 16, 2024
- Initiation Date
- Aug 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9.608 units
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Code Information
GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0033-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026