Skip to content

Medline Convenience Kits recallZ-3266-2026 · Medline Industries, LP · initiated Aug 10, 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

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An "URGENT MEDICAL DEVICE RECALL" notification letter dated 8/10/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-159-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-3266-2026
Status
Open, Classified
Initiated by the company
Aug 10, 2026
Posted by the FDA
Sep 24, 2026
Recalling firm
Medline Industries, LP
Quantity
128 kits
Product code
FDE
Distribution
US Nationwide.

Product description

Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

Code information (models, lots, serial numbers)

1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258

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 99739).

Sources and updates

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