Z-1329-2026Class II

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit...

Name: Z-1329-2026 Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit...
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: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU... 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-1329-2026
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: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.
Product code: OFF Central Venous Catheter 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: 7570 kits
Distribution: US Nationwide distribution.
Product codes and lots: 1) Kit SKU DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2026
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 OFF

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)