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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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 →Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateMedline Tracheostomy Convenience Kits Sterilization Calibration Recall
FDA (Devices) · 2026-05-13
- SevereMedline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits recalled due to sterilization equipment calibration issues
FDA (Devices) · 2026-05-13
- ModerateMedline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits recalled for potential sterilization issues
FDA (Devices) · 2026-05-13
- HighMedline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration
FDA (Devices) · 2026-05-13