Skip to content

MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY… recallZ-2485-2026 · Medline Industries, LP · initiated May 4, 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

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-2485-2026
Status
Open, Classified
Initiated by the company
May 4, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
Medline Industries, LP
Quantity
72 units
Product code
OEQ
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Product description

MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

Code information (models, lots, serial numbers)

UDI/DI 10889942113583 (each), 40889942113584 (case); Lot Numbers: DYNJ37378A, DYNJ37378A, DYNJ37378A.

Devices named in this recall

1 device 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 98994).

Sources and updates

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