Reported May 13, 2026 · Ongoing
See RES for complete list. Medline Convenience Kits
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?
See RES for complete list. Medline Convenience Kits
9 of 9 products
| Model / number | Product as published |
|---|---|
CDS860015U | MAJOR LAPAROTOMY CDS |
CDS860015V | MAJOR LAPAROTOMY CDS |
CDS860015W | MAJOR LAPAROTOMY CDS |
CDS860015X | MAJOR LAPAROTOMY CDS |
CDS860016P | MINOR LAPAROTOMY CDS |
CDS860016Q | MINOR LAPAROTOMY CDS |
CDS860016R | MINOR LAPAROTOMY CDS |
CDS860016S | MINOR LAPAROTOMY CDS |
CDS860146M | LAP GASTRIC BYPASS CDS |
- Lot codes and dates
357 of 357 products
Products covered by this recall # Barcodes Product as published 1 1019348984799440193489847995Lot Number: 21FBR386; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case) 2 1019348984799440193489847995Lot Number: 21GBS688; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case) 3 1019348984799440193489847995Lot Number: 21IBL031; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case) 4 1019348984799440193489847995Lot Number: 21KBB595; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case) 5 1019348984799440193489847995Lot Number: 21LBD726; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case) 6 1019532720958240195327209583Lot Number: 21LBT172; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case) 7 1019532734950940195327349500Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 8 1019532734950940195327349500Lot Number: 23FBP597; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 9 1019532734950940195327349500Lot Number: 23GBM065; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 10 1019532734950940195327349500Lot Number: 23HBT489; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 11 1019532734950940195327349500Lot Number: 23JBR469; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 12 1019532734950940195327349500Lot Number: 23KBX194; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case) 13 1019532764751340195327647514Lot Number: 23LBQ388; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case) 14 1019532764751340195327647514Lot Number: 24DBC504; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case) 15 1019532764751340195327647514Lot Number: 24DBP400; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case) 16 1019532764751340195327647514Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case) 17 1019532764751340195327647514Lot Number: 25DBF532; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case) 18 1019348984800740193489848008Lot Number: 25EBQ940; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case) 19 1019348984800740193489848008Lot Number: 21EBD212; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case) 20 1019348984800740193489848008Lot Number: 21FBC634; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case) - Amount recalled
- 114778 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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