Severe FDA (Devices)·Z-1385-2026·Announced 2026-02-25

Medline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns

Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. The rubric assigns a score of 4 (Severe) to FDA Class II recalls when there is potential for adverse health consequences, and the sterility assurance level of medical devices is a significant safety concern.

Plain-English summary

Medline Industries, LP is recalling 753 units of its Medline Convenience Kits, which include KIT STC TRACHEOSTOMY (Model Numbers DYKMBNDL55 and DYKMBNDL55A) and the TRACH TOTE (Model Number DYNJ85691). The recall affects products distributed worldwide, including nationwide distribution in the United States.

The recall is being issued because Medline identified issues related to the calibration of equipment used to sterilize and package the devices. While all products were exposed to the validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

Healthcare facilities and distributors that received the affected units should review their inventory using the lot numbers provided in the recall notice. The recalled products should be quarantined and not used. Medline is working with its customers to arrange for the return or replacement of affected units.

Consumers or healthcare providers with questions should contact Medline Industries, LP for further instructions regarding the recall.

The recalled product

Product: Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Manufacturer: Medline Industries, LP
Category: Medical Device — Tracheostomy Kits
Hazard: sterility-compromise
calibration-error
Affected units: 753

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

1) DYKMBNDL55
UDI-DI: 10193489478839(each)
40193489478830(case)
Lot Number: 21FBA766
2) DYKMBNDL55
Lot Number: 21DBB713
3) DYKMBNDL55
Lot Number: 21CBH955
4) DYKMBNDL55
Lot Number: 21ABX057
5) DYKMBNDL55
Lot Number: 21ABK325
6) DYKMBNDL55A
UDI-DI: 10193489897890(each)
40193489897891(case)
Lot Number: 23CBN841
7) DYKMBNDL55A
Lot Number: 22LBK911
8) DYKMBNDL55A
Lot Number: 22KBH787

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 42 products in this recall →

Same manufacturer · Medline Industries, LP

See all →

High
Medline Recalls Neurosurgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
High
Medline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
Moderate
Medline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
High
Medline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
High
Medline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02

Same hazard · sterility compromise