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.
Other recalls by Medline Industries Northfield
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FDA Drug · Class II · 2025-09-03 · Medline Industries Northfield - H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PAR…
FDA Drug · Class II · 2025-09-03 · Medline Industries Northfield - Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH…
FDA Device · Class I · 2025-09-03 · Medline Industries Northfield
All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.