Medline Industries Inc

FDA Regulatory Profile

Summary

Total Recalls
361 (46 Class I)
510(k) Clearances
266
Inspections
80
Compliance Actions
3

Known Names

medline industries, medline industries, lp - northfield, medline industries, lp - spt

Recent Recalls

NumberClassProductDate
Z-1562-2026Class IIMedline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model NumbeJanuary 30, 2026
Z-1563-2026Class IIMedline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL January 28, 2026
Z-1564-2026Class IIMedline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DJanuary 28, 2026
Z-1464-2026Class IIMedline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746January 8, 2026
Z-1465-2026Class IIConvenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A January 8, 2026
Z-1463-2026Class IIMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYJanuary 8, 2026
Z-1468-2026Class IIConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167January 8, 2026
Z-1466-2026Class IIMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 MJanuary 8, 2026
Z-1467-2026Class IIConvenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 MeJanuary 8, 2026
Z-1415-2026Class IIMedline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS,January 7, 2026
Z-1406-2026Class IIMedline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AJanuary 7, 2026
Z-1402-2026Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CEJanuary 7, 2026
Z-1405-2026Class IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AJanuary 7, 2026
Z-1419-2026Class IIMedline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYNJanuary 7, 2026
Z-1394-2026Class IIMedline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEJanuary 7, 2026
Z-1425-2026Class IIMedline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOUJanuary 7, 2026
Z-1418-2026Class IIMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, ModJanuary 7, 2026
Z-1396-2026Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER January 7, 2026
Z-1409-2026Class IIMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPJanuary 7, 2026
Z-1397-2026Class IIMedline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY UREJanuary 7, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K251687Konig Bell Circumcision ClampFebruary 25, 2026
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)November 20, 2025
K250345Medline Bag DecanterOctober 24, 2025
K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus July 2, 2025
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemApril 11, 2025
K242844Medline Level 4 Surgical Gown with Breathable SleevesFebruary 26, 2025
K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (14093December 19, 2024
K241778Hudson RCI Comfort Flo® CubCannula™December 19, 2024
K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaSeptember 27, 2024
K234132Medline Reusable Sterilization WrappersSeptember 17, 2024
K241359Medline UNITE® MIS Foot Recon Screw SystemAugust 2, 2024
K234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult June 4, 2024
DEN210049Medline ART Skin Harvesting SystemMarch 27, 2024
K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)March 26, 2024
K233526Medline Open-back Level 3 Protective GownMarch 5, 2024
K230235Medline Luer Lock SyringesFebruary 16, 2024
K231058Hudson RCI® AddiPak® Unit Dose VialJanuary 4, 2024
K231211Medline ComfortTemp Patient Warming SystemDecember 1, 2023
K230602Hudson RCI® TurboMist™ Nebulizer SystemOctober 31, 2023
K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable HuOctober 26, 2023