The Recall Desk
ModerateFDA (Devices)·Z-1221-2022·Announced 2022-06-08

MEDLINE Polyurethane Foam Bedside Cleaning Kit Recalled for Microbial Contamination

MEDLINE has recalled certain lots of its Polyurethane Foam Bedside Cleaning Kit due to microbial contamination detected on the foam sponge. Sporadic reports of discoloration were identified as contamination.

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: This is an FDA Class II recall for microbial contamination without any reported illnesses or injuries. No specific pathogen type is identified, and reports are described as sporadic. This fits the rubric for low-risk contamination.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling certain lots of the MEDLINE Polyurethane Foam Bedside Cleaning Kit (REF DYK100FS), a product used in healthcare bedside cleaning. Sporadic reports of discoloration on the foam sponge were identified as microbial contamination.

The recall affects approximately 699 boxes of 50 units each, distributed in the United States and Panama. Affected lot codes follow the format YYMMDD X, where YY represents the year of production, MM the month, DD the day, and X the leading number of the raw material batch number.

Consumers and healthcare facilities should stop using affected lots and contact MEDLINE INDUSTRIES, LP for guidance on return or replacement.

The recalled product

Product
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
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) 40888277367396
  • MM is the number of the month of production

Distribution

Distribution scope not specified by the agency.