Povidone Solution Labeled Sterile Despite Non-Sterile Contents
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—non-sterile contents mislabeled as sterile—qualifies as a risk-of-harm medical device product where injury has not yet been reported, fitting Score 3 (High) criteria.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 300 units of Sterile Povidone (Reference DYNDA2061, UDI 40889942697633 for cases and 10889942697632 for individual units), packaged in foil sachets.
The product labeling indicates the contents are 'Sterile' or 'STRL,' but the solution inside the foil sachets has been found to be non-sterile. This mismatch between the label and actual product condition means users may receive material they believe to be sterile when it is not.
The affected lots are 2022040790 and 2022062190, distributed nationwide to facilities in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida.
The FDA classifies this as a Class II recall. No illnesses or injuries have been reported. Healthcare facilities and users should stop using affected units and contact Medline Industries or the FDA for instructions on proper handling.
The recalled product
- Product
- STERILE POVIDONE, REF DYNDA2061
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 40889942697633 (case)
- 10889942697632 (each)
- Lot numbers: 2022040790
- 2022062190
Distribution
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · non sterile
See all →- SevereBeekeeper's Naturals saline nasal spray recalled for microbial contamination
FDA (Drugs) · 2026-06-17
- HighMedline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline medical convenience kits recalled for non-sterile alcohol prep pads
FDA (Devices) · 2026-05-06
Similar recalls
- HighMedline PVP solution mislabeled as sterile when non-sterile
FDA (Devices) · 2023-07-19
- ModerateMedline Non-Sterile PVP Solution Mislabeled as Sterile Product
FDA (Devices) · 2023-07-19
- HighMedline Non-Sterile PVP Solution Mislabeled as Sterile
FDA (Devices) · 2023-07-19
- HighMedical Laboratory Kit Recalled Due to Non-Sterile Specimen Container
FDA (Devices) · 2024-11-20
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20
- SevereMedline Staple Remover Kit Recalled for Subpotent Iodine Concentration
FDA (Drugs) · 2018-02-07