FDA Device recall Z-0032-2025
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 by Medline Industries Northfield, citing 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, a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0032-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-30 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Reason
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.
Identifiers
| code_info | GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2025%22
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