Z-0033-2025Class II

Medline Automatic Digital Blood Pressure Unit, Ref Mds1001u

Name: Z-0033-2025 Medline Automatic Digital Blood Pressure Unit, Ref Mds1001u
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-08-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-08-30 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U on 2024-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0033-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-08
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Automatic Digital Blood Pressure Unit, Ref Mds1001u.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 9.608 units
Distribution: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Product codes and lots: GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0033-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0032-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09
Z-0033-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09
Z-0034-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09

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)