Food, drugs, devices › MEDLINE INDUSTRIES, LP - Northfield
Device recall: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
FDA enforcement event 95318 is a device recall by MEDLINE INDUSTRIES, LP - Northfield of Northfield, IL, initiated 30 Aug 2024 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. MEDLINE INDUSTRIES, LP - Northfield has 120 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
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."
Distribution
"Worldwide distribution - US Nationwide and the countries of Panama and Jamaica."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0032-2025 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 | 52,521 units | Class II | Ongoing | 16 Oct 2024 |
| Z-0033-2025 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. | 9.608 units | Class II | Ongoing | 16 Oct 2024 |
| Z-0034-2025 | MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. | 7,428 units | Class II | Ongoing | 16 Oct 2024 |
Context
Other enforcement events for MEDLINE INDUSTRIES, LP - Northfield
All 120 events for MEDLINE INDUSTRIES, LP - Northfield
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 the unit warm to the touch."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Panama and Jamaica."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.