MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

Recall Insight

This FDA Devices action (record #Z-0033-2025) was formally reported on October 16, 2024, with the manufacturer initiating the action on August 30, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 9.608 units units are affected.

The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.