FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
- Recall number
- Z-1459-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
- Status
- Open, Classified
- Initiated
- 2024-02-26
- Posted
- 2024-04-01
- Terminated
- not on file
- Reason
- The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
- Root cause
- Nonconforming Material/Component
- Action
- Medline Industries, LP issued a Medical Device Recall notice to its consignees on 02/26/2024 via USPS and email. The notice explained the problem with the device and requested requested destruction of affected product. Distributors or anyone who further distributed or sold the product is directed to notify their customers. Questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 74,339 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- a) MDS4001, UDI/DI 100888277361228, Lot Numbers: 230280001, 230380001, 230680001, 230780001, 230880001; b) MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003; c) MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004
- 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