MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
FDA device recall Z-0033-2025 · posted 2024-10-08 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DXN
- Quantity affected
- 9.608 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
- Date initiated
- 2024-08-30
- Date posted
- 2024-10-08
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Automatic Upper Arm Blood Pressure Monitor (K193627) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |