FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
- Recall number
- Z-0032-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
- Status
- Open, Classified
- Initiated
- 2024-08-30
- Posted
- 2024-10-08
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 52,521 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
- Lot, serial or model codes
- GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005
- 510(k) numbers
- ["K193627"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28