MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF… recallZ-1217-2022 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 21, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated the recall by letter on 04/21/2022
Recall details
- Recall number
- Z-1217-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 500 boxes of 100 units
- Product code
- MNL
- Distribution
- US and Panama
Product description
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Code information (models, lots, serial numbers)
DI: (01) 40888277367358; 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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90125).
- Z-1218-2022 · Open, ClassifiedMEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
- Z-1219-2022 · Open, ClassifiedMEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
- Z-1220-2022 · Open, ClassifiedMEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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