This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
LRO - Sterile Medline Convenience Kits:
- MAJOR PACK L-F, Model Number: DYNJ0382730O
- LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
OJH – Sterile Medline Convenience Kits:
- EXTREMITY PACK, Model Number: DYNJ45701B
What to Do
- Do not use affected kits.
- Respond to the firm with all requested information.
On August 8, 2025, Medline Industries reached out to the five affected customers asking for confirmation on the number of affected units and to hold those kits.
On August 22, 2025, Medline Industries, LP sent all five affected customers an Urgent Medical Device Recall notice providing formal documentation of the recall.
Medline will provide disposition as soon as possible.
Reason for Recall
Medline Industries, LP is recalling certain sterile Medline Convenience Kits due to mislabeling as sterile without completing the sterilization process. These convenience kits were manufactured at a Medline site and shipped directly to distribution centers instead of to the sterilization site first. These kits, meant to be sterile, were shipped non-sterilized to distribution centers, where the affected lots were released to a small number of customers.
The use of affected product may cause serious adverse health consequences, including bloodstream infection, fevers, sepsis and death.
There have been no reported injuries or deaths related to this issue.
Device Use
DYNJ0382730O (Major Pack L-F): This pack is a convenience custom pack that supports general surgery procedures in adult patients. Procedures may include abdominal procedures such as bowel resections and appendectomies.
DYNJ45701B (Extremity Pack): This pack is a convenience custom pack that supports orthopedic surgery procedures in adult patients. Procedures may include knee replacement, ankle ORIF and foot surgeries.
DYNJ61038B (LB Basic Custom Pack): This pack is a convenience custom pack that would support general surgery procedures in pediatric patients, such as hernia repairs.
The contents of all three of these packs include products that establish the sterile field, which supports patient safety and infection prevention.
Contact Information
Customers in the U.S. with questions about this recall should contact Medline Industries at 1-866-359-1704.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
