Non-sterile Betadine solution labeled and distributed as sterile
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
What this means for you
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: FDA Class II recall for a medical device with a significant quality defect—the product is labeled as sterile but contains non-sterile solution. No illnesses or injuries have been reported, but a non-sterile product in a medical context poses a risk of harm.
Plain-English summary
Medline Industries, LP is recalling 1,800 units of Sterile Betadine, Reference Number DYNDA1998. The product labeling indicates the contents are 'Sterile' or 'STRL,' but the solution inside the foil sachet is non-sterile. This means the product does not meet its stated specifications.
The affected units were distributed nationwide in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida, with lot numbers 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, and 2021100490.
The recalled product
- Product
- STERILE BETADINE, REF DYNDA1998
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- non-sterile
- mislabeling
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 (9)
- UDI/DI 40889942651062 (case)
- 10889942651061 (each)
- Lot numbers: 2023042190
- 2022101090
- 2022081590
- 2022041390
- 2022031090
- 2022011290
- 2021100490
Distribution
Distributed nationwide across the United States.
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