Z-1330-2026Class II

1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C...

Name: Z-1330-2026 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C...
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 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5)... 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-1330-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-24
Posted: 2026-02-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
Product code: LRO General Surgery 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: 21854 units
Distribution: US Nationwide distribution.
Product codes and lots: 1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2026
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 LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

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)