Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1459-2024 · Posted 2024-04-01

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeDXN
Date Initiated2024-02-26
Product Quantity74,339 units

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

Firm 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].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193627Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑