Medline Industries, Inc.
Medline Industries, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2024, with 104 FDA device recalls on record.
Top product codes for Medline Industries, Inc.
FDA recalls by Medline Industries, Inc.
10 most recent of 104- Z-1683-2022 — Medline CHEST TUBE REORDER NO: DYNJ36762A
- Z-0360-2022 — Major Vascular CDS Convenience Kit
- Z-0358-2022 — EVLP Convenience Pack/Kit
- Z-0359-2022 — Neuro Convenience Kit
- Z-0362-2022 — Bedside PICC CDS Convenience Kit
- Z-0361-2022 — Venous Access Pack-LF Convenience Kit
- Z-2575-2021 — NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (10) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055003, UPN H965700550031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (11) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055008, UPN H965700550081, Three-way Stopcock with Rotating Adapter, Rx only, Sterile; (12) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055009, UPN H965700550091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; and (13) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055017, UPN H965700550171, One-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile.
- Z-2574-2021 — NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile. (5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (9) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038301, UPN H965700383011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (10) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038303, UPN H96570038301, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (11) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039202, UPN H965700392021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (12) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039301, UPN H965700393011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; and (13) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039303, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.
- Z-2233-2021 — Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Z-2234-2021 — Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
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, Inc.
1–100 of 238- DEN210049 — Medline ART Skin Harvesting System
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
- K212911 — Konig Mogen Clamp
- K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- K213481 — Medline General Surgery Tray
- K212093 — Medline Universal Grounding Pad
- K213068 — Medline Smoke Evacuation Shroud
- K211612 — Medline UNITE REFLEX Dynamic Discs
- K212258 — Medline Cardiovascular Procedure Kit
- K211931 — Medline Digital Thermometer Non-Lubricated Probe Sheath
- K203538 — SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K211944 — Medline UNITE® Digital Fusion Screw System
- K203135 — Medline Vacu-line Suction Aspirator
- K210482 — Medline UNITE REFLEX Nitinol Staple System
- K202447 — Medline Orbis Surgical Gown
- K210526 — Medline Cautery Tip Cleaner
- K202668 — Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
- K202449 — Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
- K200150 — Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
- K202179 — Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
- K202285 — Medline ENfit OTC Feeding Syringe
- K201290 — Medline DeNovo 4Pro Electrical Stimulation Device
- K201829 — SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K193666 — Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff +1 more
- K193217 — SensiCare PI and SensiCare PI Micro Surgical Gloves
- K192988 — Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
- K191753 — Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
- K191915 — SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
- K192820 — SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K192641 — Gemini Titan Sterilization Wrap
- K192985 — Medline Glide-On 3G Vinyl Examination Gloves
- K192315 — Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K192104 — Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
- K191759 — Medline Quick Switch Valve with ENFit Connector
- K191378 — 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- K190950 — Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
- K183431 — Medline Digital Rectal Thermometer Sheath
- K183335 — Medline Poly-Cath Red Polymer Urethral Catheter
- K190643 — Medline Electrocautery Pencil
- K183577 — Medline Quick-Clear Wand
- K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
- K190224 — Medline Burn and Wound Dressing (OTC)
- K181782 — Medline Reinforced Epidural Catheter
- K182812 — Medline Cautery Electrode (SILICONE)
- K181820 — Medline Unite Mini Plates and Screws
- K181726 — Medline Patient Cables and Lead Wires
- K173911 — Medline Burn and Wound Dressing
- K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
- K173348 — 0.9% Sodium Chloride Injection, USP
- K172954 — Medline Prevention CoolZone Gown
- K180696 — Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
- K173889 — Medline Cautery Electrode (PTFE)
- K172541 — Medline Catheter Specimen Collector
- K173113 — Medline Disposable Electronic Thermometer Probe Cover
- K170002 — Medline Blood Collection Set
- K170415 — Medline Hemo-Force DVT Compression Sleeve
- K170782 — Medline UNITE® Snap-Off Screws
- K162993 — Gemini Sterilization Wrap
- K162982 — Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K160471 — Medline Non-Surgical Isolation Gown-
- K160660 — Medline Waste Station
- K162829 — Medline UNITE® Ankle Fracture Plating System
- K160642 — Medline ENFit Syringe
- K161473 — Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
- K152564 — Gemini Sterilization Wrap
- K161035 — Medline Singe Patient Use Blood Pressure Cuff
- K152458 — Gemini Bonded Sterilization Wrap
- K150598 — Blockade Surgical Gown
- K152428 — SensiCare PI Surgical Gloves
- K151754 — Glide-On Vinyl Examination Gloves
- K150731 — Medline Epidural Catheter
- K152948 — Medline Anti-Fog Solution
- K150238 — SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
- K150698 — Gemini Sterilization Wrap
- K143693 — MEDLINE SHARPS CONTAINERS
- K143529 — UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
- K151235 — Medline Foot Plates and Screws
- K151628 — Medline ENFit Connectors
- K143322 — Medline Natural Lubricating Liquid
- K143147 — Gemini Bonded Sterilization Wrap
- K150286 — Medline Enteral Feeding Sets
- K142635 — Medline Silicone Foley Catheter
- K140369 — MEDLINE NEURO SPONGE
- K141127 — MEDLINE ANTI-EMBOLISM STOCKING
- K131426 — MEDLINE BIOPSY VALVE
- K132767 — MEDLINE SHARPS CONTAINER
- K122949 — MEDLINE SUCTION COAGULATOR
- K132314 — MEDLINE ANTI-REFLUX VALVE
- K130319 — MEDLINE CANNULATED SCREW
- K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER
- K113353 — GEMINI STERILZATION WRAP
- K120008 — MEDLINE HIGH PRESSURE INJECTION TUBING
- K113583 — CURAD ANTIBACTERIAL BANDAGE
- K120069 — MEDLINE STOPCOCK AND MANIFOLD
- K112769 — CURAD COMPRESSION HOSIERY
- K111955 — MEDLINE PNEUMOPERITONEUM NEEDLE
- K111577 — MEDLINE VIAL DECANTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.