The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Medline Industries Inc

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Same hazard · subpotent antiseptic

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