Z-1221-2022Class II

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS

Name: Z-1221-2022 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-04-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-04-21 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS on 2022-04-21. FDA classified it as Class II and gives the reason as "Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1221-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-21
Posted: 2022-06-02
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 04/21/2022
Quantity in commerce: 699 boxes of 50 units
Distribution: US and Panama
Product codes and lots: DI: (01) 40888277367396; 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1221-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1217-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02
Z-1218-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02
Z-1219-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02
Z-1220-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02
Z-1221-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)