Medline Tracheostomy Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text explicitly states that products were exposed to validated sterilization cycles and no illnesses or injuries are reported; the hazard is a potential impact on sterility assurance level that is theoretical in nature. The FDA classification is Class II, and in the absence of reported harm or a high-risk pathogen, this meets the criteria for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, including Model Numbers DYKMBNDL55, DYKMBNDL55A, and DYNJ85691 (TRACH TOTE). The recall affects 753 units distributed nationwide in the United States and worldwide.
The recall was initiated because of calibration issues identified in the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Patients and healthcare providers who have received these kits should contact Medline Industries for instructions on returning or replacing the affected products. The specific lot numbers affected are listed in the recall notice.
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
- Hazard
- sterility-assurance
- equipment-calibration
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: 21ABK325
- 2) DYKMBNDL55
- Lot Number: 21ABX057
- 3) DYKMBNDL55
- Lot Number: 21CBH955
- 4) DYKMBNDL55
- Lot Number: 21DBB713
- 5) DYKMBNDL55
- Lot Number: 21FBA766
- 6) DYKMBNDL55A
- UDI-DI: 10193489897890(each)
- 40193489897891(case)
- Lot Number: 21FBE305
- 7) DYKMBNDL55A
- Lot Number: 21FBS122
- 8) DYKMBNDL55A
- Lot Number: 21GBR275
Distribution
Distributed nationwide across the United States.
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