Z-1334-2026Class II

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO...

Name: Z-1334-2026 Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO...
Creator: Medline Industries, LP
Published: 2025-12-24
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-24 / Open, Classified / root cause: packaging

FDA source

Medline Industries, LP began a recall of 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... on 2025-12-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1334-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-24
Posted: 2026-02-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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.
Product code: OXQ Dressing Change Tray
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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].
Quantity in commerce: 8445 kits
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1334-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1326-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1327-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1328-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1329-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1330-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1331-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1332-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1333-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1334-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1335-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09
Z-1336-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09

Product code OXQ

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)