CLASS II ONGOING Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

Medline Polyurethane Bedside Cleaning Kit recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Polyurethane Bedside Cleaning Kit. The recall was initiated on 21 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDI: (01) 40888277367372; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.

Quantity recalled500 boxes of 100 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1219-2022
FDA event ID: 90125
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 21 Apr 2022
FDA classified: 2 Jun 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

21 Apr 2022	Recall initiated by company
2 Jun 2022	Classified by FDA	+42 days
8 Jun 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW

Where it was distributed

US and Panama

Questions about this recall

Is Medline Polyurethane Bedside Cleaning Kit recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Polyurethane Bedside Cleaning Kit on 21 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1219-2022.

Why was it recalled?

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

Which lots are affected?

DI: (01) 40888277367372; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.

Where was it sold?

US and Panama

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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