Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0264-2018·Announced 2018-02-07

Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

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. The hazard is a subpotent antiseptic, which is a quality defect without reported harm, fitting the Moderate criteria for low-risk contamination or labeling/quality errors without severe injury reports.

Plain-English summary

Medline Industries, Inc. is recalling 65,563 cases of Medline Suture Removal Trays. 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 products are sterile, single-use trays packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall covers specific pack numbers DYND70900 and DYND70900H and multiple lot numbers, including 17GB6098, 16KB8714, and 17EB4268.

The products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Healthcare providers and consumers should check their inventory for these specific lot and pack numbers and stop using the affected trays.

The recalled product

Product: Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Manufacturer: Medline Industries Inc
Category: Medical Device — Surgical Supplies
Hazard: subpotent-antiseptic
quality-defect
Affected units: 65,563

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 (20)

Pack Number: DYND70900
Lots: 17GB6098
16KB8714
17GB5103
17EB4268
17BB3409
17SB1821
17OB8226
16QB7895
17EB7214
16LB5336
17QB4767
17MB3722
17PB7167
17EB0363
17DB2103
17FB2572 Pack Number: DYND70900H
Lots: 16KB8714
16WB5947
17GB6098

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 68 products in this recall →

Same manufacturer · Medline Industries Inc

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Same hazard · subpotent antiseptic