The Recall Desk
ModerateFDA (Devices)·Z-1220-2022·Announced 2022-06-08

Medline Polyurethane Foam Bedside Cleaning Kit recalled for microbial contamination

Medline Industries recalls Polyurethane Foam Bedside Cleaning Kits due to sporadic reports of discoloration on foam sponges caused by microbial contamination. The recall affects 22,765 boxes distributed in the US and Panama.

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: FDA Class II recall of unspecified microbial contamination with no reported illnesses or injuries. This constitutes low-risk contamination without documented evidence of patient harm, fitting the Moderate severity category.

Plain-English summary

Medline Industries, LP is recalling MEDLINE Polyurethane Foam Bedside Cleaning Kits (REF DYK215FS) due to microbial contamination. The recall involves 22,765 boxes of 50 units each that were distributed in the United States and Panama.

Sporadic reports were received of discoloration on the foam sponge in certain lots of the product, which has been identified as microbial contamination. The FDA has classified this as a Class II recall.

Healthcare facilities and others who may have received this product should check their inventory using the product reference number and lot number information to determine if they have affected units. Contact Medline Industries for information about affected lot numbers and guidance on replacing the product.

The recalled product

Product
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • microbial-contamination

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 (2)

  • DI: (01) 40888277367365
  • MM is the number of the month of production

Distribution

Distribution scope not specified by the agency.