Medline Skin Biopsy Pack Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Skin Biopsy Packs because the iodine concentration is below the label claim.
The agency’s classification
FDA (Drugs): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a subpotent antiseptic agent without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Medline Industries, Inc. is recalling 120 cases of Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. The recall is due to the titratable iodine contained in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected product is identified by Pack Number DYNJ0394028 and Lots 17HK3191. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare providers should stop using the affected product and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Affected units
- 120
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 (2)
- Pack Number: DYNJ0394028
- Lots 17HK3191
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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