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Medline Convenience Kits containing select SKUs of 10mL… recallZ-1892-2026 · 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

Unapproved design changes to the products outside of the 510(k) clearance.

FDA root cause category: Component change control

What the company is doing

On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.

Recall details

Recall number
Z-1892-2026
Status
Open, Classified
Initiated by the company
Feb 27, 2026
Posted by the FDA
Apr 17, 2026
Recalling firm
Medline Industries, LP
Quantity
270,311 total
Product code
OJF
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Product description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G

Code information (models, lots, serial numbers)

DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556

Devices named in this recall

2 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 98601).

Sources and updates

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