Reported Apr 10, 2024 · Ongoing

Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Blood Pressure Unit
  • Model (REF) Numbers
    • a) MDS4001
    • b) MDS4001LA
    • c) MDS4001PLUS
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
1230280001, 230380001, 230680001, 230780001, 230880001
2MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003
3MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004
Amount recalled
74,339 units

This recall covers 30 products

The agency filed one notice per product. You are reading one of them; the other 29 are below.

17 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.