Agency classClass IIOur severity:High FDA (Devices)·Z-0033-2025·Announced 2024-10-16

Medline Blood Pressure Monitor Recalled for Microchip Failure and Overheating

Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.

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 recall of a malfunctioning blood pressure monitor with a faulty microchip. Although the device presents a potential risk of harm through overheating, no illnesses or injuries have been reported. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Medline Industries, LP is recalling the Medline Automatic Digital Blood Pressure Unit, Model MDS1001U. Approximately 9,608 units are affected, distributed worldwide, including the United States, Panama, and Jamaica. The units are identified by GTIN 00888277704049 and the following lot numbers: L230480007, L230880007, L231080007, L231280007, and L240380007.

The recalled devices contain a faulty microchip that causes device malfunctions. Affected units may fail to power on, show display screen issues after the initial few uses, or overheat during operation, making the unit warm to the touch.

Consumers and healthcare professionals who possess these blood pressure monitors should check whether they have affected units by verifying the model number and lot numbers. Anyone with an affected unit should contact Medline Industries for additional instructions or replacement.

The recalled product

Product: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Blood Pressure Monitor
Hazard: microchip-failure
power-failure
display-malfunction
overheating

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 (5)

GTIN 00888277704049. Lot Numbers: L230480007
L230880007
L231080007
L231280007
L240380007

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.

See all 3 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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