Medline Industries Recalls Tracheostomy Convenience Kits Due to Sterility Concerns

What Happened

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

Which Products Are Affected

A total of 753 units are included in this recall. The affected products were distributed worldwide and nationwide across the United States.

Affected Models and Lot Numbers:

1. KIT STC TRACHEOSTOMY (Model Number: DYKMBNDL55)

   • UDI-DI: 10193489478839 (each), 40193489478830 (case)
   • Lot Numbers: 21FBA766, 21DBB713, 21CBH955, 21ABX057, 21ABK325

2. KIT STC TRACHEOSTOMY (Model Number: DYKMBNDL55A)

   • UDI-DI: 10193489897890 (each), 40193489897891 (case)
   • Lot Numbers: 23CBN841, 22LBK911, 22KBH787, 22HBQ099, 22FBX191, 22FBF305, 22DBR042, 22DBM224, 22BBM867, 22BBL555, 22ABM691, 22ABD970, 21WBA902, 21JBJ227, 21IBU128, 21GBR277, 21GBR275, 21FBS122, 21FBE305

3. TRACH TOTE (Model Number: DYNJ85691)

   • UDI-DI: 10195327534141 (each), 40195327534142 (case)
   • Lot Number: 24ABR853

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and consumers should immediately check their inventory for the model and lot numbers listed above. If you possess any of the recalled products, follow the specific instructions for return or disposal provided in the firm’s notification letter.

Why This Matters

Sterility is critical for medical devices used in tracheostomy procedures. If the sterility assurance level is compromised, there is an increased risk of infection or other serious health complications for patients using these kits.

Source

This information is based on an official recall notice from the FDA under recall number Z-1385-2026.