Z-2595-2026Class II

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF...

Name: Z-2595-2026 Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF...
Creator: Medline Industries, LP
Published: 2026-02-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified / root cause: design

FDA source

Medline Industries, LP began a recall of Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A on 2026-02-27. FDA classified it as Class II and gives the reason as "Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2595-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-06-25
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Product code: MCY Wound Dressing Kit
Reason for recall: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Root cause tag: design
FDA root cause: No Marketing Application
Action: This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
Quantity in commerce: 113, 843 kits
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Product codes and lots: DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2595-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2581-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2582-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2583-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2584-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2585-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2586-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2587-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2588-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2589-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2590-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2591-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2592-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2593-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2594-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2595-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2596-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25

Product code MCY

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)