Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Numbe
Summary
The FDA issued a Class I for Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O by Medline Industries, LP. Reason: Convenience kits labeled as sterile have not gone through the sterilization process..
Details
Source
Device Recall
External ID
Z-2592-2025
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Lot/Code Info: 1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;
Quantity Affected: 22 units
Reason for Recall
Convenience kits labeled as sterile have not gone through the sterilization process.
Distribution
US Distribution to States of: FL, MD, NJ, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-08
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 168 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2592-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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