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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

MEDLINE INDUSTRIES, LP - Northfield: Digital Blood Pressure Monitors Recalled for Faulty Microchip and Overheating

Agency Publication Date: October 8, 2024
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Summary

Medline Industries is recalling approximately 69,587 Automatic Digital Blood Pressure Monitors because a faulty microchip can cause the device to fail to power on or display screen errors. In some cases, the units may also overheat, making them warm to the touch and potentially unreliable for accurate health monitoring. This recall affects three models (MDS1001, MDS1001U, and MDS1001UT) distributed worldwide and across the United States. Consumers should check their specific lot numbers and model codes to see if their device is part of this recall.

Risk

A defective microchip causes the monitor to malfunction or overheat during use. This can lead to the device being unable to provide critical blood pressure readings or posing a minor burn risk if the unit becomes excessively warm to the touch.

What You Should Do

  1. Check your blood pressure monitor for the model number REF MDS1001, MDS1001U, or MDS1001UT printed on the device or packaging.
  2. Verify your lot number against the following affected lists: for model MDS1001, check for L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, or L240280005.
  3. For model MDS1001U, check for lot numbers L230480007, L230880007, L231080007, L231280007, or L240380007.
  4. For model MDS1001UT, check for lot numbers L230480008, L230780008, L231080008, L231280008, or L240280008.
  5. If your unit matches the affected models and lot numbers, stop using the device for clinical monitoring and contact your healthcare provider or Medline Industries for further instructions and potential refund.
  6. For more information, contact Medline Industries at their Northfield, Illinois headquarters or call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT
Model / REF:
MDS1001
UPC Codes:
00888277629656
Lot Numbers:
L230380005
L230480005
L230580005
L230680005
L230780005
L230980005
L231080005
L231180005
L231280005
L240280005
Product: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT
Model / REF:
MDS1001U
UPC Codes:
00888277704049
Lot Numbers:
L230480007
L230880007
L231080007
L231280007
L240380007
Product: MEDLINE Automatic Digital Blood Pressure Monitor
Model / REF:
MDS1001UT
UPC Codes:
00193489012548
Lot Numbers:
L230480008
L230780008
L231080008
L231280008
L240280008

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95318
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 3 products (52,521 units; 9.608 units; 7,428 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.