Medline Industries, LP
Medline Industries, LP holds FDA 510(k) medical device clearances, first cleared 2022, most recent 2026, with 513 FDA device recalls on record.
Top product codes for Medline Industries, LP
FDA recalls by Medline Industries, LP
10 most recent of 513- Z-0189-2027 — Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
- Z-0281-2027 — MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
- Z-0275-2027 — MEDLINE medical convenience kits labeled as (list truncated)
- Z-0278-2027 — MEDLINE medical convenience kits labeled as: (list truncated)
- Z-0277-2027 — MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.
- Z-0272-2027 — MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
- Z-0280-2027 — MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
- Z-0270-2027 — MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
- Z-0279-2027 — MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
- Z-0273-2027 — MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medline Industries, LP
- K253526 — NAMIC Dilator and Sheath
- K254287 — Medline Reusable Blood Pressure Cuff
- K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- K251687 — Konig Bell Circumcision Clamp
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
- K250345 — Medline Bag Decanter
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
- K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System
- K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves
- K241778 — Hudson RCI Comfort Flo® CubCannula
- K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
- K234132 — Medline Reusable Sterilization Wrappers
- K241359 — Medline UNITE® MIS Foot Recon Screw System
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
- K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- K233526 — Medline Open-back Level 3 Protective Gown
- K230235 — Medline Luer Lock Syringes
- K231058 — Hudson RCI® AddiPak® Unit Dose Vial
- K231211 — Medline ComfortTemp Patient Warming System
- K230602 — Hudson RCI® TurboMist Nebulizer System
- K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit
- K231907 — Medline Safety Insulin and TB Syringes
- K231885 — Medline UNITE® REFLEX® Nitinol Staple System
- K223236 — Medline Surgical Face Mask and Medline Procedural Face Mask
- K220365 — Gemini Sterilization Wrap
- K221360 — Medline UNITE® Medial Malleolus Peg Plate System
- K220333 — Medline Orbis LVL 3 Surgical Gown
- K214108 — Medline Orbis Chemo Surgical Gown
- K220511 — Medline UNITE IM Fibula Implant
- K213567 — Medline UNITE Calcaneal Fracture Plating System
Data sourced from openFDA. This site is unofficial and independent of the FDA.