Medline Automatic Digital Blood Pressure Monitors Recalled for Power, Display, and Overheating Issues
Medline is recalling 52,521 automatic digital blood pressure monitors due to a faulty microchip that may cause power failures, display screen issues, or overheating. Consumers should stop using affected units immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. While the overheating presents a theoretical burn risk, the hazards are functional defects with no documented harm yet reported. This meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling the Automatic Digital Blood Pressure Unit (Model MDS1001, GTIN 00888277629656) due to a faulty microchip. The recall affects approximately 52,521 units distributed nationwide in the United States and in Panama and Jamaica.
The faulty microchip has caused certain units to fail to power on, display screen issues after initial use, and overheating that makes the device warm to the touch. These defects prevent proper operation of the blood pressure monitor.
Affected lot numbers are L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, and L240280005. Consumers who have purchased this device should discontinue use and contact the manufacturer for return or replacement information. For additional details, refer to FDA recall number Z-0032-2025.
The recalled product
- Product
- MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 52,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- GTIN 00888277629656
- Lot Numbers: L230380005
- L230480005
- L230580005
- L230680005
- L230780005
- L230980005
- L231080005
- L231180005
- L231280005
- L240280005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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