Z-1459-2024Class II

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

Name: Z-1459-2024 Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-02-26
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-26 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS on 2024-02-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1459-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-26
Posted: 2024-04-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline Industries, LP issued a Medical Device Recall notice to its consignees on 02/26/2024 via USPS and email. The notice explained the problem with the device and requested requested destruction of affected product. Distributors or anyone who further distributed or sold the product is directed to notify their customers. Questions: contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 74,339 units
Distribution: US Nationwide distribution.
Product codes and lots: a) MDS4001, UDI/DI 100888277361228, Lot Numbers: 230280001, 230380001, 230680001, 230780001, 230880001; b) MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003; c) MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1459-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1459-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01

Product code DXN

K193627Class IIAutomatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. / cleared 2020-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)