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Centurion Medical Products Corp recallZ-1334-2026 · Medline Industries, LP · initiated Dec 24, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

FDA root cause category: Packaging change control

What the company is doing

Medline issued an URGENT MEDICAL DEVICE recall notice to its consignees on 12/24/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee locate and quarantine the affected units and respond to the notice using the website link: https://recalls.medline.com; Recall Reference #: R-25-257-FGX1, and the specific code listed in the notice. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who further distributed the affected its were directed to notify those to whom the kits were distributed or transferred, and include those quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-1334-2026
Status
Open, Classified
Initiated by the company
Dec 24, 2025
Posted by the FDA
Feb 9, 2026
Recalling firm
Medline Industries, LP
Quantity
8445 kits
Product code
OXQ
Distribution
US Nationwide distribution.

Product description

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

Code information (models, lots, serial numbers)

1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881; 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827; 3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730; 4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629; 5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086; 6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081; 7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351; 8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085; 9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98284).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page