FDA Device Recall Z-2593-2025

Medline Industries, LP · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Lot / serial / GTIN: 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686

Quantity: 88 units

Reason for recall

Convenience kits labeled as sterile have not gone through the sterilization process.

Recall record

Recall number: Z-2593-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Distribution to States of: FL, MD, NJ, TN
Recall initiated: 2025-08-08
Classified by FDA Center: 2025-09-26
FDA published: 2025-10-08
Recalling firm: Medline Industries, LP
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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