Reported May 13, 2026 · Ongoing
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, 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) CENTRAL LINE UNIVERSAL INSERTI
- Model Number
CVI37802) LVAD DRIVELINE TRAY
- Model Number
DM10353) KIT SURG ONC INSERT CENT.VENOU
- Model NumberDYKMBNDL43
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 1019348943486640193489434867Lot Number: 23KBO637; 2) CVI3780, UDI-DI: 10193489434866(each), 40193489434867(case) 2 1019348944275540193489442756Lot Number: 24ABC276; 3) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case) 3 1019348947889140193489478892Lot Number: 21BBN221; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 4 1019348947889140193489478892Lot Number: 21ABJ003; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 5 1019348947889140193489478892Lot Number: 21ABO838; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 6 1019348947889140193489478892Lot Number: 21DBD662; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 7 1019348947889140193489478892Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 8 1019348947889140193489478892Lot Number: 21JBJ253; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 9 1019348947889140193489478892Lot Number: 22CBU342; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 10 1019348947889140193489478892Lot Number: 22EBL039; 11) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 11 1019348947889140193489478892Lot Number: 22GBF510; 12) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case) 12 Lot Number: 22GBN333 - Amount recalled
- 1056 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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