Reported May 13, 2026 · Ongoing
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline Convenience Kits1) KIT STC TRACHEOSTOMY
- Model Number
DYKMBNDL552) KIT STC TRACHEOSTOMY
- Model Number
DYKMBNDL55A3) TRACH TOTE
- Model NumberDYNJ85691
- Lot codes and dates
25 of 25 products
Products covered by this recall # Barcodes Product as published 1 1019348947883940193489478830Lot Number: 21ABK325; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case) 2 1019348947883940193489478830Lot Number: 21ABX057; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case) 3 1019348947883940193489478830Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case) 4 1019348947883940193489478830Lot Number: 21DBB713; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case) 5 1019348989789040193489897891Lot Number: 21FBA766; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 6 1019348989789040193489897891Lot Number: 21FBE305; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 7 1019348989789040193489897891Lot Number: 21FBS122; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 8 1019348989789040193489897891Lot Number: 21GBR275; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 9 1019348989789040193489897891Lot Number: 21GBR277; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 10 1019348989789040193489897891Lot Number: 21IBU128; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 11 1019348989789040193489897891Lot Number: 21JBJ227; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 12 1019348989789040193489897891Lot Number: 21WBA902; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 13 1019348989789040193489897891Lot Number: 22ABD970; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 14 1019348989789040193489897891Lot Number: 22ABM691; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 15 1019348989789040193489897891Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 16 1019348989789040193489897891Lot Number: 22BBM867; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 17 1019348989789040193489897891Lot Number: 22DBM224; 18) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 18 1019348989789040193489897891Lot Number: 22DBR042; 19) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 19 1019348989789040193489897891Lot Number: 22FBF305; 20) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) 20 1019348989789040193489897891Lot Number: 22FBX191; 21) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case) - Amount recalled
- 753 units
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
This product could cause temporary or reversible health problems — stop using it.
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