Medline Industries Inc
Medline Industries Inc appears in FDA public data with 725 recalls — including 100 Class I (most serious) —, 269 510(k) clearances, 83 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-3126-2026, Class I) was initiated on August 11, 2026. Its most recent 510(k) clearance was granted on July 29, 2026.
Summary
- Total Recalls
- 725 (100 Class I)
- 510(k) Clearances
- 269
- Inspections
- 83
- Compliance Actions
- 4
Known Names
medline industries, medline industries, lp - northfield, medline industries, lp - spt
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3126-2026 | Class I | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: | August 11, 2026 |
| Z-3123-2026 | Class I | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL L | August 11, 2026 |
| Z-3122-2026 | Class I | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM | August 11, 2026 |
| Z-3127-2026 | Class I | Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: | August 11, 2026 |
| Z-3125-2026 | Class I | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: | August 11, 2026 |
| Z-3121-2026 | Class I | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A | August 11, 2026 |
| Z-3124-2026 | Class I | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Numbe | August 11, 2026 |
| Z-3207-2026 | Class II | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A | July 31, 2026 |
| Z-3208-2026 | Class II | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F | July 31, 2026 |
| Z-3210-2026 | Class II | Convenience kits CATARACT PACK DYNJ59881A | July 31, 2026 |
| Z-3209-2026 | Class II | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A | July 31, 2026 |
| Z-3137-2026 | Class II | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N | July 23, 2026 |
| Z-3071-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-S | July 20, 2026 |
| Z-3079-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT | July 20, 2026 |
| Z-3076-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B | July 20, 2026 |
| Z-3078-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT D | July 20, 2026 |
| Z-3070-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERI | July 20, 2026 |
| Z-3069-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42 | July 20, 2026 |
| Z-3067-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS | July 20, 2026 |
| Z-3072-2026 | Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/C | July 20, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253526 | NAMIC Dilator and Sheath | July 29, 2026 |
| K254287 | Medline Reusable Blood Pressure Cuff | June 22, 2026 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99 | March 25, 2026 |
| K251687 | Konig Bell Circumcision Clamp | February 25, 2026 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | November 20, 2025 |
| K250345 | Medline Bag Decanter | October 24, 2025 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus | July 2, 2025 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | April 11, 2025 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | February 26, 2025 |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (14093 | December 19, 2024 |
| K241778 | Hudson RCI Comfort Flo® CubCannula | December 19, 2024 |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | September 27, 2024 |
| K234132 | Medline Reusable Sterilization Wrappers | September 17, 2024 |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | August 2, 2024 |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult | June 4, 2024 |
| DEN210049 | Medline ART Skin Harvesting System | March 27, 2024 |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | March 26, 2024 |
| K233526 | Medline Open-back Level 3 Protective Gown | March 5, 2024 |
| K230235 | Medline Luer Lock Syringes | February 16, 2024 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | January 4, 2024 |