November 24, 2025 — United States.
The U.S. Food and Drug Administration (FDA) has confirmed that the recall involving several sterile surgical convenience kits manufactured by Medline Industries, LP remains active, with no indication that the process has been completed. While the company has communicated with healthcare facilities and initiated corrective actions, the FDA’s official recall alert still lists the case as ongoing, as regulators continue to await final disposition details from Medline.
The recall, first communicated to affected customers in August 2025, involves potential breaches in sterility that could pose a risk for severe infection if the affected kits are used in surgical or procedural settings. No injuries or deaths have been reported to date, but the FDA continues to advise healthcare providers to ensure that all affected inventory is removed from use immediately.
Medline’s recall began after the company identified issues involving a limited number of sterile convenience kits that may have been compromised during the packaging or sterilization process. According to the FDA’s alert, Medline issued initial notice to five customers on August 8, 2025, requesting confirmation of affected stock. This was later followed by a formal “Urgent Medical Device Recall” letter sent on August 22, outlining the required steps for identifying, segregating, and returning the impacted kits.
The recalled products include three specific models:
• Major Pack L-F (DYNJ0382730O)
• LB Basic Custom Pack (DYNJ61038B)
• Extremity Pack (DYNJ45701B)
These kits are typically used in operating rooms and outpatient surgical environments, meaning any sterility breach could put patients at risk of surgical site infections or other serious complications.
Although the number of product models is small, the contents of these kits are integral to sterile procedures, making correct handling of the recall essential for patient safety.
FDA: Alert Still Active, Final Disposition Still Pending
As of late November 2025, the FDA’s online recall alert has not been closed and continues to display active status. One of the key reasons is that Medline has not yet provided its final “disposition” report, a required summary detailing the number of affected units recovered, removed from circulation, or destroyed.
The agency states that Medline “will provide the disposition as soon as possible,” indicating that the recall process is still underway. In many cases, recalls remain open until the FDA receives full documentation verifying that all affected units have been accounted for, corresponding actions have been completed, and the risk has been mitigated.
Without this final step, regulators cannot formally close the case.
No Reported Injuries, but Risks Remain Serious
The FDA’s alert confirms that no adverse events, patient injuries, or deaths have been reported in connection with the recalled Medline kits. However, regulators emphasize that using a non-sterile kit—particularly during invasive procedures—may lead to:
• Surgical site infections
• Sepsis
• Extended hospital stays
• Repeat surgeries
• Serious or life-threatening complications in vulnerable patients
For this reason, Medline and the FDA strongly advise healthcare facilities not to use any identified units still in inventory.
Hospitals, ambulatory surgery centers, and supply chain managers are advised to continue following recall procedures until the FDA issues an official closure. Recommended steps include:
1. Audit all inventory
Facilities should cross-check supply shelves, procedure carts, OR storage, and inbound shipments to ensure no affected kits remain in circulation.
2. Follow Medline’s return instructions
Medline’s recall letter provides details on segregating and returning affected kits. Facilities can coordinate directly with the company to arrange retrieval.
