RecallRadar
FDA · Medical devicesClass I

Medline Industries, LP medical device recall: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F

Sterility concernsLabeling errors

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
97495
Recall initiated
Aug 8, 2025
Classified by FDA
Sep 26, 2025
Posted in Enforcement Report
Oct 8, 2025
Recalling firm
Medline Industries, LP
Firm location
Northfield, IL, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 8, 2025. FDA classified it 49 days later, on Sep 26, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US Distribution to States of: FL, MD, NJ, TN Medline Industries, LP has 257 recalls in our records.

Recalled products (2)

  • Z-2592-2025 Class I Ongoing

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

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

    Quantity: 22 units

  • Z-2593-2025 Class I Ongoing

    Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

    Codes / lots: 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686

    Quantity: 88 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 97495
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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