Medline procedure kits labeled as recallZ-1042-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 18, 2024
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
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.
Recall details
- Recall number
- Z-1042-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2024
- Posted by the FDA
- Jan 28, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 250 units
- Product code
- OXQ
- Distribution
- US Nationwide distribution.
Product description
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Code information (models, lots, serial numbers)
1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case), Lot Numbers: 2024030690, 2024041990, 2024082390.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE DYNDC3189Medline Industries, Inc. · Dressing change tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96110).
- Z-1040-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
- Z-1041-2025 · Open, ClassifiedMedline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
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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