Medline Industries Inc

FDA Regulatory Profile

Summary

Total Recalls
392 (65 Class I)
510(k) Clearances
267
Inspections
80
Compliance Actions
3

Known Names

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

Recent Recalls

NumberClassProductDate
Z-1824-2026Class IICENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050FMarch 16, 2026
Z-1721-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1728-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1718-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027;February 27, 2026
Z-1712-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 700750February 27, 2026
Z-1714-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1726-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1722-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1723-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1725-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1713-2026Class INAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, MedlFebruary 27, 2026
Z-1715-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1729-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1730-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1724-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1727-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1719-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1720-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1716-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringFebruary 27, 2026
Z-1717-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027;February 27, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99March 25, 2026
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
K241778Hudson RCI Comfort Flo® CubCannula™December 19, 2024
K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (14093December 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