Healthcare professionals and supply managers, please be aware of an urgent recall announced by Medline Industries, LP. The company is removing certain sterile Medline Convenience Kits that were mislabeled as sterile despite not completing the sterilization process. According to the FDA, this issue presents severe safety risks, including potential bloodstream infections and other serious health consequences.
What changed?
On August 22, 2025, Medline Industries, LP formally initiated this recall by notifying all five affected customers through an Urgent Medical Device Recall notice. The recall applies to three specific convenience kits shipped from a Medline manufacturing site directly to distribution centers without undergoing sterilization. This serious oversight resulted in non-sterile products being released for use in medical procedures.
Although no injuries or deaths have been reported as of the recall date, the FDA has classified this recall as the most serious type due to the potential for severe adverse events, including bloodstream infections, sepsis, and death.
Who is affected?
The recall impacts only five customers who received the affected units. However, all healthcare facilities, surgical teams, and regulatory compliance officers are advised to take note of this announcement to prevent possible usage of non-sterile kits in surgical procedures. Patients undergoing general or orthopedic surgeries may face a heightened risk of infection if these kits are used.
The affected models include:
- MAJOR PACK L-F, Model Number: DYNJ0382730O – Intended for general surgery procedures in adults, including bowel resections and appendectomies.
- EXTREMITY PACK, Model Number: DYNJ45701B – Designed for orthopedic surgeries in adults, such as knee replacements, ankle fixation, and foot surgeries.
- LB BASIC CUSTOM PACK, Model Number: DYNJ61038B – Crafted for general surgery procedures in pediatric patients, such as hernia repairs.
These kits contain multiple components that help establish a sterile field, an essential safety measure for preventing infections during surgical procedures.
What are the risks?
The primary risk stems from procedures performed with non-sterile kits labeled as sterile. These products are intended to maintain a sterile environment during surgeries. A breach in sterilization increases the possibility of introducing harmful pathogens into the patient’s body, potentially leading to severe conditions, including:
- Bloodstream infections
- Sepsis
- Complications prolonging recovery or requiring additional treatment
- Death in the most severe cases
What should customers do?
Medline Industries has requested all affected customers take the following steps immediately:
- Stop the use of all affected kits.
- Provide information on the quantity of affected products in their possession.
- Hold the recalled kits until further instructions are received for their disposition.
Healthcare professionals and consumers should remain vigilant about not using these kits and reporting any quality issues to the appropriate channels.
How to report issues?
Adverse reactions or quality concerns involving these kits should be reported directly to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. Additionally, customers in the U.S. with questions about this recall can contact Medline Industries at 1-866-359-1704.
What role does the UDI play?
The recalled products are identifiable through their Unique Device Identifier (UDI). This system allows the tracking of medical devices from manufacturing to patient use. The UDI ensures quicker identification of potentially harmful devices, streamlining withdrawal from the market and enhancing device safety overall.
Conclusion
This recall underscores the critical need for robust sterilization and labeling practices in medical device manufacturing. Stakeholders, including hospital procurement teams and infection control professionals, should act promptly to identify and isolate the affected kits. Patient safety remains paramount, and adherence to FDA recall guidelines will minimize risks associated with this recall.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice. Always review FDA guidelines and consult compliance experts for official directives.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-medline-industries-lp-removes-certain-sterile-medline-convenience-kits