Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1218-2022·Announced 2022-06-08

MEDLINE Polyurethane Foam Bedside Cleaning Kit Recalled for Microbial Contamination

MEDLINE has recalled its Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS) in the United States and Panama after sporadic reports of discoloration. The discoloration has been identified as microbial 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 Class II recall involved no reported illnesses or injuries. The microbial contamination identified through discoloration represents a precautionary recall of a low-risk item without documented harm, consistent with voluntary precautionary recalls.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling the Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS). The recall encompasses 4,033 boxes containing 25 units each, distributed throughout the United States and Panama.

Sporadic reports have been received of discoloration on the foam sponge in certain product lots. Investigation identified the discoloration as microbial contamination.

The affected product bears the identifier DI: (01)40888277367389. Affected lots are marked with Envirolite lot numbers in the format YYMMDD X, where YY represents the last two digits of production year, MM represents the production month, DD represents the production day, and X represents the leading number of the raw material batch number. Consumers who have received this product should inspect their kits for discoloration and contact MEDLINE for further guidance.

The recalled product

Product: MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Cleaning Supplies
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)40888277367389
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.

See all 5 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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