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Medline convenience kits containing Healthmark Instrument… recallZ-3229-2026 · 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

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

FDA root cause category: Under Investigation by firm

What the company is doing

Firm began notifying consignees on August 10, 2026. Customers may continue to use Instrument Channel Brushes contained in Medline convenience kits in accordance with recommendations from the manufacturer of the brushes, Healthmark: Customers should be aware of possible sharp burrs when handling and utilizing Instrument Channel Brushes. If a sharp burr is discovered, discard or return the brush.

Recall details

Recall number
Z-3229-2026
Status
Open, Classified
Initiated by the company
Aug 10, 2026
Posted by the FDA
Sep 18, 2026
Recalling firm
Medline Industries, LP
Quantity
90 kits (US)
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution in the states of MN and SD.

Product description

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.

Code information (models, lots, serial numbers)

DYNJ48258D UDI-DI 10889942563272 Lots 23CBH459 23GBJ128 24ABM400

Devices named in this recall

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

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99729).

Sources and updates

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