FDA Device recall Z-0531-2024
STERILE POVIDONE, REF DYNDA2061
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of STERILE POVIDONE, REF DYNDA2061 by Medline Industries Northfield, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-03 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
STERILE POVIDONE, REF DYNDA2061
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.
Identifiers
| code_info | UDI/DI 40889942697633 (case), 10889942697632 (each), Lot numbers: 2022040790, 2022062190 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2024%22
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