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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
Part of a larger recall action
This product is one of 5 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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