Medline Industries, LP

FDA Regulatory Profile

Summary

Total Recalls
594 (83 Class I)
510(k) Clearances
267
Inspections
80
Compliance Actions
4

Known Names

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

Recent Recalls

NumberClassProductDate
Z-2481-2026Class IIMEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline ProducMay 4, 2026
Z-2507-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377May 4, 2026
Z-2504-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; May 4, 2026
Z-2479-2026Class IIMEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DMay 4, 2026
Z-2505-2026Class IIMEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HMay 4, 2026
Z-2480-2026Class IIMEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French siMay 4, 2026
Z-2501-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2May 4, 2026
Z-2495-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DMay 4, 2026
Z-2493-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJMay 4, 2026
Z-2499-2026Class IIMEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044May 4, 2026
Z-2496-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483May 4, 2026
Z-2488-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2May 4, 2026
Z-2482-2026Class IIMEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (May 4, 2026
Z-2497-2026Class IIMEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see thMay 4, 2026
Z-2490-2026Class IIMEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253AMay 4, 2026
Z-2502-2026Class IIMEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820BMay 4, 2026
Z-2484-2026Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline PrMay 4, 2026
Z-2486-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) May 4, 2026
Z-2487-2026Class IIMEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGMay 4, 2026
Z-2483-2026Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline PrMay 4, 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