MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT — Class II medical device recall Z-0033-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-16, distributed nationwide. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power
| Recall number | Z-0033-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-08-30 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | JM, PA |
| Quantity | 9.608 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00888277704049 |
| Lot numbers | L230480007, L230880007, L231080007, L231280007, L240380007 |
| Model numbers | MDS1001U |
Product
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0033-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.