Medline Newborn Kit Recalled for Subpotent Povidone-Iodine Prep Pads
Medline Industries is recalling 288 cases of Newborn Kits because the Povidone-Iodine prep pads contain subpotent iodine, falling below the 0.85% 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, but the source text does not report any illnesses or injuries, and the hazard is a subpotent drug issue rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or labeling issues.
Plain-English summary
Medline Industries, Inc. is recalling 288 cases of Medline Newborn Kits. The recall is due to the titratable iodine content in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected product is identified by Pack Number DYKL1133 and Lots 17IA0348 and 17GA0975. The product was distributed nationwide in the United States, 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 Povidone-Iodine prep pads and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 288
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)
- Pack Number: DYKL1133
- Lots: 17IA0348
- 17GA0975
- 17IA0348
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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