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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: Blood Pressure Units Recalled for Manufacturing Non-Compliance

Agency Publication Date: April 1, 2024
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Summary

Medline Industries is recalling 74,339 blood pressure monitoring units across three specific models: MDS4001, MDS4001LA, and MDS4001PLUS. These devices were manufactured in a way that does not meet the company's own quality specifications, but were mistakenly accepted into inventory and distributed to customers. Because the devices are non-compliant with design standards, you should contact the manufacturer or your healthcare provider to ensure you are receiving accurate health readings.

Risk

The affected units do not meet established manufacturing specifications, which could potentially lead to inaccurate blood pressure readings. Inaccurate readings may cause patients to seek unnecessary medical treatment or delay necessary care for hypertension or other cardiac conditions.

What You Should Do

  1. Identify if you have an affected unit by checking the model number and lot number on the device label or packaging. Affected models include MDS4001, MDS4001LA, and MDS4001PLUS.
  2. For Model MDS4001 (UDI/DI 100888277361228), check for lot numbers: 230280001, 230380001, 230680001, 230780001, and 230880001.
  3. For Model MDS4001LA (UDI/DI 100884389106955), check for lot numbers: 230480003, 230780003, and 231180003.
  4. For Model MDS4001PLUS (UDI/DI 100888277362089), check for lot numbers: 230280004, 230480004, 230780004, and 231080004.
  5. If your device matches one of these lot numbers, contact your healthcare provider for guidance and contact Medline Industries at 1-800-633-5463 for instructions regarding the non-compliant units.
  6. For additional questions, contact the FDA's consumer hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider contact

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

Affected Products

Product: Blood Pressure Unit MDS4001
Model / REF:
MDS4001
Lot Numbers:
230280001
230380001
230680001
230780001
230880001
Product: Blood Pressure Unit MDS4001LA
Model / REF:
MDS4001LA
Lot Numbers:
230480003
230780003
231180003
Product: Blood Pressure Unit MDS4001PLUS
Model / REF:
MDS4001PLUS
Lot Numbers:
230280004
230480004
230780004
231080004

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94134
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 74,339 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.