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Convenience kits containing select SKUs of 10mL… recallZ-2584-2026 · Medline Industries, LP · initiated Feb 27, 2026

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

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

FDA root cause category: No Marketing Application

What the company is doing

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.

Recall details

Recall number
Z-2584-2026
Status
Open, Classified
Initiated by the company
Feb 27, 2026
Posted by the FDA
Jun 25, 2026
Recalling firm
Medline Industries, LP
Quantity
113,843 kits
Product code
FTN
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 description

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702

Code information (models, lots, serial numbers)

DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ66746 UDI-DI 10193489375527 Lot 24BBD114 DYNJ85702 UDI-DI 10195327536213 Lot 24ABP053

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 99062).

Sources and updates

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