The Recall Desk
HighFDA (Devices)·Z-1219-2022·Announced 2022-06-08

MEDLINE Polyurethane Bedside Cleaning Kits Recalled Due to Microbial Contamination

MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with confirmed microbial contamination on a healthcare product, meeting the criterion for a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been documented.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling certain lots of the MEDLINE Polyurethane Bedside Cleaning Kit (REF DYK500FSAW), a bedside cleaning product distributed in the United States and Panama. The recall affects 500 boxes of 100 units each.

Sporadic reports were received of discoloration on the foam sponge of certain lots. The FDA investigation identified this discoloration as microbial contamination. No illnesses or injuries associated with this product have been reported.

Affected lots are identified by an Envirolite lot number on individual packaging in the format YYMMDD X, where YY represents the last two digits of the year of production, MM is the month number, DD is the day, and X is the leading number of the raw material batch number.

The recalled product

Product
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
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) 40888277367372
  • MM is the number of the month of production

Distribution

Distribution scope not specified by the agency.