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MEDLINE Medical Procedure Kits labeled as recallZ-2500-2026 · 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-2500-2026
Status
Open, Classified
Initiated by the company
May 4, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
Medline Industries, LP
Quantity
342 units
Product code
OJG
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: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.

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 98994).

Sources and updates

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