FDA Medical devices recall ·
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT recall
- Recall number
- Z-0033-2025
- Date
- (initiated August 30, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9.608 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0033-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.