The Recall Desk
ModerateFDA (Devices)·Z-1544-2020·Announced 2020-04-01

Medline Stick Sponge Presaturated W/PVP Recalled for Packaging Seal Voids

Medline is recalling Stick Sponge Presaturated W/PVP units due to packaging seal voids that compromise sterility.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Medline Industries Inc is recalling 1,541,532 units of Medline Stick Sponge Presaturated W/PVP, reference numbers DYND70288 and DYND70288H, with an expiration date of 06/30/2022. The recall was initiated because voids were discovered in the packaging seal, resulting in a loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

The affected products were distributed nationwide across 38 states and the District of Columbia, including Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Consumers and healthcare facilities should stop using the affected products and contact Medline Industries Inc for further instructions or a refund. The recall is classified as Class II by the FDA.

The recalled product

Product
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Affected units
1,541,532

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 (1)

  • REF DYND70288 2/PK Expiration 06/30/2022

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →