FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: STERILE BETADINE, REF DYNDA1998
- Recall number
- Z-0530-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- STERILE BETADINE, REF DYNDA1998
- Status
- Open, Classified
- Initiated
- 2023-11-03
- Posted
- 2023-12-11
- Terminated
- not on file
- Reason
- The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.
- Quantity
- 1800 units
- Distribution
- US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
- Lot, serial or model codes
- UDI/DI 40889942651062 (case), 10889942651061 (each), Lot numbers: 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, 2021100490
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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