Medline Industries Recalls Tracheostomy Convenience Kits Due to Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP has voluntarily recalled 753 units of Tracheostomy Convenience Kits and Trach Totes due to equipment calibration issues that may compromise product sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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:
KIT STC TRACHEOSTOMY (Model Number: DYKMBNDL55)
- UDI-DI: 10193489478839 (each), 40193489478830 (case)
- Lot Numbers: 21FBA766, 21DBB713, 21CBH955, 21ABX057, 21ABK325
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
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.