Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medline Industries, Inc. is recalling 1,133 cases of Medline Suture Removal Trays, Sterile, Single Use Only. The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDR1109 with Lots 17NB0789 and 17EB4269, and Pack Number DYNDR1109H with Lot 17EB4269. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Healthcare facilities and consumers should stop using the affected suture removal trays and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 1,133
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: DYNDR1109
- Lots: 17NB0789
- 17EB4269 Pack Number: DYNDR1109H
- Lots 17EB4269
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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