Medline Industries Recalls 5,346 Medical Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of various medical convenience kits due to potential sterility assurance issues. The company identified calibration errors in the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization cycles, these calibration issues have the potential to impact the sterility assurance level (SAL) of the finished products.

Which Products Are Affected

Approximately 5,346 units are affected by this recall. The products were distributed nationwide in the United States and worldwide. The recall includes 24 distinct model numbers across various medical kits:

• PICC LINE TRAY: Models 00-401993O, DYNJ40500A, PICCNC0004
• CODE CART ADULT 4 CENTRAL LINE: Models ACC010268B, ACC010268C
• TRAY 6 CENTRAL LINE A: Model ACC010487
• PEDS PICC INSERTION TRAY: Model CVI3650
• LINE ATTIRE KIT: Model DYKM2170
• KIT SURG ONC (Various): Models DYKMBNDL153C, DYKMBNDL43A, DYKMBNDL43C
• VEIN PROCEDURE KIT/PACK: Models DYNDA2076B, DYNDA2076D, DYNDA2076F, DYNJ84239
• PLACENTA KIT: Model DYNDA2322B
• NICU CENTRAL LINE TRAY: Models DYNDC2407A, DYNDC2407B
• VENOUS ACCESS PACK: Model DYNJ42694C
• AV FISTULA CREATION PACK-LF: Model DYNJ53427B
• PICC LINE/TRAY: Models DYNJ55546D, DYNJ63199A
• PICC KIT (Various): Models DYNJ70141MB, DYNJ70152MB

Affected lot numbers include, but are not limited to: 23KBH528, 24DDA188, 23IDA297, 24KDA478, 23HDA348, 22EBO541, 23BBA792, 24DBR907, 23BBS866, 24DBS686, 24ABI534, 24LMH364, 25KMH542, 23FBW064, 22FME865, 25IMA418, 23HBB480, 24ABW686, 20LDC151, 23GBK664, 22JBN171, 21ADA546, 21ADA547, 23FBJ937, and 23LMD502.

What You Should Do

Healthcare facilities and providers should immediately inspect their inventory for the affected model and lot numbers. Medline Industries, LP began notifying customers of the issue via letter on January 7, 2026. Users should follow the specific instructions provided in the firm’s notification regarding the quarantine and return of affected products. For further assistance, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is critical for medical devices used in invasive procedures. Compromised sterility assurance in kits used for central line or venous access can increase the risk of patient infection and related medical complications.

Source

Information provided by the FDA under Recall Number Z-1391-2026.