CLASS I ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report

Sterile Medline Convenience Kits: Major Pack recalled

Medline Industries is recalling Sterile Medline Convenience Kits: Major Pack L-f, distributed in Florida, Maryland, New Jersey, Tennessee. The recall was initiated on 8 Aug 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;

Quantity recalled22 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2592-2025
FDA event ID: 97495
Recalling firm: Medline Industries, Northfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 8 Aug 2025
FDA classified: 26 Sep 2025
Reported: 8 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Aug 2025	Recall initiated by company
26 Sep 2025	Classified by FDA	+49 days
8 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Convenience kits labeled as sterile have not gone through the sterilization process.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

Where it was distributed

US Distribution to States of: FL, MD, NJ, TN

Florida Maryland New Jersey Tennessee

Questions about this recall

Why was it recalled?

Convenience kits labeled as sterile have not gone through the sterilization process.

Which lots are affected?

1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;

Where was it sold?

US Distribution to States of: FL, MD, NJ, TN

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97495

This product is part of a recall event; the main page for the event is Sterile Medline Convenience Kits: Extremity Pack recalled.

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025	CLASS I	Sterile Medline Convenience Kits: Extremity Pack recalled	Medline Industries	Sterility	4 states

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