Medline Automatic Digital Blood Pressure Unit, Ref Mds1001 recallZ-0032-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.
Recall details
- Recall number
- Z-0032-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 30, 2024
- Posted by the FDA
- Oct 8, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 52,521 units
- Product code
- DXN
- FDA submissions
- K193627
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Product description
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Code information (models, lots, serial numbers)
GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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