Medline Industries recalled 420 Sterile Radiology Procedure Kits, Model DYNDH1491B, distributed nationwide in Minnesota after a potential breach in sterile pouch packaging. The defect may compromise product sterility. Stop using the kit immediately and contact Medline or your healthcare provider for instructions.
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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Sterile radiology procedure kits are used to prepare and maintain a sterile field during radiology imaging procedures. They are intended for use in hospital and clinical settings.
A breach in the sterile pouch packaging can allow microbial contamination of the kit contents. Using such a kit could lead to infection or other procedure-related complications.
This recall is not described as part of a broader industry pattern.
Healthcare facilities may need to quarantine the affected lot and assess patient procedures that used the kit. The impact is primarily clinical and operational, with potential infection risk for patients.
Serial numbers and lot numbers are printed on the kit packaging and outer box. Use the FDA recall page for official identifiers.
Refund or replacement process is determined by Medline Industries, LP; expect weeks to several weeks.
Retain recall notification, take photos of packaging and label, maintain records of all communications with supplier and healthcare providers.
Model: DYNDH1491B. UDI-DI: CS 40198459071455. EA code: 10198459071454. Lot number: 25GBB924. Brand: Medline Industries, LP. Quantity: 420 units. Distribution: US nationwide, MN. Recall date: 2026-02-18. Status: ACTIVE. Country of origin: Unknown.
No injuries or incidents have been reported.
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