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Medline convenience kit recallZ-2430-2026 · Medline Industries, LP · initiated Apr 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

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

FDA root cause category: Process control

What the company is doing

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

Recall details

Recall number
Z-2430-2026
Status
Open, Classified
Initiated by the company
Apr 27, 2026
Posted by the FDA
Jun 12, 2026
Recalling firm
Medline Industries, LP
Quantity
49,654 kits total
Product code
MLT
Distribution
US Nationwide distribution. OUS distribution pending.

Product description

Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

Code information (models, lots, serial numbers)

UDI-DI 10198459028274 Lot 25LMI820

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 98951).

Sources and updates

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