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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · microchip failure
See all →- HighMedline Blood Pressure Monitor Recalled for Microchip Failure and Overheating
FDA (Devices) · 2024-10-16
Similar recalls
- HighMedline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance
FDA (Devices) · 2024-04-10
- SevereWelch Allyn ProBP 2400 Digital Blood Pressure Device Recall
FDA (Devices) · 2017-04-19
- HighMedtronic O-arm Imaging System Recalled for High Voltage Relay Overheating
FDA (Devices) · 2012-08-29
- HighMedline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect
FDA (Devices) · 2025-04-02
- ModerateMedline Heart Overhead Table Pack recalled for incorrect model labeling
FDA (Devices) · 2024-10-23
- SevereNamic Preceptor Manifold blood pressure transducers recalled for particulate contamination
FDA (Devices) · 2026-05-20