FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Leg bag, REF URO12573
- Recall number
- Z-0535-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Leg bag, REF URO12573
- Status
- Open, Classified
- Initiated
- 2023-10-19
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- Undeclared latex
- Root cause
- Labeling mix-ups
- Action
- Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.
- Quantity
- 144 devices
- Distribution
- US and Panama
- Lot, serial or model codes
- UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FAQ
- 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