MEDLINE Digital Blood Pressure Monitor Recalled Due to Microchip Faults
MEDLINE is recalling 7,428 Automatic Digital Blood Pressure Monitors due to a faulty microchip causing power-on failures, display issues, and overheating. Units were distributed in the US, Panama, and Jamaica.
What this means for you
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 FDA Class II recall involves a medical device with demonstrated field failures including power-on failures, display malfunctions, and overheating—a risk-of-harm product where no injuries have yet been reported. The device malfunctions prevent proper operation and the overheating presents a potential burn risk to patients.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling 7,428 units of its Automatic Digital Blood Pressure Monitor (REF MDS1001UT) due to a faulty microchip that has caused device failures in the field.
Affected units contain a defective microchip that has caused them to fail to power on, experience display screen malfunctions, and overheat to the point of becoming warm to the touch. These issues have been observed after initial use. The affected lot numbers are L230480008, L230780008, L231080008, L231280008, and L240280008 (GTIN 00193489012548).
The recalled monitors were distributed worldwide, including throughout the United States, Panama, and Jamaica. Consumers who own affected units should stop using them and contact MEDLINE for further instructions regarding return or replacement.
The recalled product
- Product
- MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 7,428
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 00193489012548 Lot Numbers: L230480008
- L230780008
- L231080008
- L231280008
- L240280008
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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