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.
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 3/5 (High).
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
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.
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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