The Recall Desk
HighFDA (Devices)·Z-1217-2022·Announced 2022-06-08

MEDLINE Enzymatic Cleaning Sponges Recalled Due to Microbial Contamination

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was 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 recall is classified as FDA Class II and involves microbial contamination on a medical device. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) distributed in the United States and Panama.

The FDA received sporadic reports of discoloration on the foam sponge in certain lots. The discoloration has been identified as microbial contamination. Approximately 500 boxes of 100 units each are affected.

The recalled product

Product
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
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) 40888277367358
  • MM is the number of the month of production

Distribution

Distribution scope not specified by the agency.

Related recalls

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