Company · US
Medline Industries, LP
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
269510(k) clearances (5 in 12 months)
723recalls (566 in 12 months)
111recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRO | General Surgery Tray | 89 |
| OEZ | Cardiovascular Procedure Kit | 34 |
| OJH | Orthopedic Tray | 32 |
| OFF | Central Venous Catheter Tray | 22 |
| OGR | Ear, Nose, And Throat Surgical Tray | 22 |
| FDE | Laparoscopy Kit | 21 |
| FYA | Gown, Surgical | 20 |
| OES | Cardiac Catheterization Kit | 20 |
| OHD | Gynecological Laparoscopic Kit | 20 |
| OEQ | Angiography/Angioplasty Kit | 19 |
| OJG | Neurological Tray | 18 |
| OHM | Cesarean Section Tray | 17 |
| PUI | Drape, Surgical, Exempt | 16 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 15 |
| FTN | Plastic Surgery And Accessories Kit | 15 |
| OJK | Eye Tray | 15 |
| KGO | Surgeon'S Gloves | 14 |
| INI | Vehicle, Motorized 3-Wheeled | 13 |
| LZA | Polymer Patient Examination Glove | 13 |
| OFG | Ct Biopsy Tray | 12 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2026 | K253526 | NAMIC Dilator and Sheath Medline Industries, LP | DYB |
| Jun 22, 2026 | K254287 | Medline Reusable Blood Pressure Cuff Medline Industries, LP | DXQ |
| Mar 25, 2026 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech wi Medline Industries, LP | BZE |
| Feb 25, 2026 | K251687 | Konig Bell Circumcision Clamp Medline Industries, LP | HFX |
| Nov 20, 2025 | K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) Medline Industries, LP | DXC |
| Oct 24, 2025 | K250345 | Medline Bag Decanter Medline Industries, LP | LHI |
| Jul 2, 2025 | K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small Medline Industries, LP | BTT |
| Apr 11, 2025 | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System Medline Industries, LP | JDR |
| Feb 26, 2025 | K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves Medline Industries, LP | FYA |
| Dec 19, 2024 | K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) Medline Industries, LP | GEI |
| Dec 19, 2024 | K241778 | Hudson RCI Comfort Flo® CubCannula Medline Industries, LP | BTT |
| Sep 27, 2024 | K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula Medline Industries, LP | BTT |
| Sep 17, 2024 | K234132 | Medline Reusable Sterilization Wrappers Medline Industries, LP | FRG |
| Aug 2, 2024 | K241359 | Medline UNITE® MIS Foot Recon Screw System Medline Industries, LP | HWC |
| Jun 4, 2024 | K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD9909 Medline Industries, LP | BZE |
| Mar 27, 2024 | DEN210049 | Medline ART Skin Harvesting System Medline Industries, Inc. | QYK |
| Mar 26, 2024 | K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) Medline Industries, LP | FRO |
| Mar 5, 2024 | K233526 | Medline Open-back Level 3 Protective Gown Medline Industries, LP | QPC |
| Feb 16, 2024 | K230235 | Medline Luer Lock Syringes Medline Industries, LP | FMF |
| Jan 4, 2024 | K231058 | Hudson RCI® AddiPak® Unit Dose Vial Medline Industries, LP | CAF |
| Dec 1, 2023 | K231211 | Medline ComfortTemp Patient Warming System Medline Industries, LP | DWJ |
| Oct 31, 2023 | K230602 | Hudson RCI® TurboMist Nebulizer System Medline Industries, LP | CAF |
| Oct 26, 2023 | K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Medline Industries, Inc. | BTT |
| Oct 19, 2023 | K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit Medline Industries, LP | JDR |
| Oct 18, 2023 | K231907 | Medline Safety Insulin and TB Syringes Medline Industries, LP | MEG |
| Aug 9, 2023 | K231885 | Medline UNITE® REFLEX® Nitinol Staple System Medline Industries, LP | JDR |
| Jun 27, 2023 | K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) Medline Industries, Inc. | CAF |
| Mar 24, 2023 | K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask Medline Industries, LP | FXX |
| Jan 25, 2023 | K222665 | Medline UNITE® Ankle Fusion Plating System Medline Industries, Inc. | HRS |
| Dec 9, 2022 | K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe Medline Industries, Inc. | FMF |
| Nov 18, 2022 | K212911 | Konig Mogen Clamp Medline Industries, Inc. | HFX |
| Oct 25, 2022 | K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser Medline Industries, Inc. | BWF |
| Oct 6, 2022 | K220365 | Gemini Sterilization Wrap Medline Industries, LP | FRG |
| Sep 27, 2022 | K221360 | Medline UNITE® Medial Malleolus Peg Plate System Medline Industries, LP | HRS |
| May 24, 2022 | K213481 | Medline General Surgery Tray Medline Industries, Inc. | LRO |
| May 18, 2022 | K220333 | Medline Orbis LVL 3 Surgical Gown Medline Industries, LP | FYA |
| May 6, 2022 | K214108 | Medline Orbis Chemo Surgical Gown Medline Industries, LP | FYA |
| Mar 22, 2022 | K220511 | Medline UNITE IM Fibula Implant Medline Industries, LP | HWC |
| Mar 2, 2022 | K213567 | Medline UNITE Calcaneal Fracture Plating System Medline Industries, LP | HRS |
| Jan 14, 2022 | K212093 | Medline Universal Grounding Pad Medline Industries, Inc. | GEI |
| Jan 3, 2022 | K213068 | Medline Smoke Evacuation Shroud Medline Industries, Inc. | FYD |
| Dec 10, 2021 | K211612 | Medline UNITE REFLEX Dynamic Discs Medline Industries, Inc. | HTN |
| Dec 3, 2021 | K212258 | Medline Cardiovascular Procedure Kit Medline Industries, Inc. | LRO |
| Sep 20, 2021 | K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath Medline Industries, Inc. | FLL |
| Aug 2, 2021 | K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. | KGO |
| Jul 22, 2021 | K211944 | Medline UNITE® Digital Fusion Screw System Medline Industries, Inc. | HWC |
| May 4, 2021 | K203135 | Medline Vacu-line Suction Aspirator Medline Industries, Inc. | BTA |
| Apr 22, 2021 | K210482 | Medline UNITE REFLEX Nitinol Staple System Medline Industries, Inc. | JDR |
| Apr 2, 2021 | K202447 | Medline Orbis Surgical Gown Medline Industries, Inc. | FYA |
| Mar 12, 2021 | K210526 | Medline Cautery Tip Cleaner Medline Industries, Inc. | GEI |
Newest 50 of 269.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C;
2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B. Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
(list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP 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 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N;
2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D;
3) OB/GYN, Medline Kit Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as (list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R;
2) MAJOR, Medline Kit Number/SKUDYNJ904851I;
3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUD Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101 Open, Classified |
PUI | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A Open, Classified |
KCY | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135A
CHN GYN ONCOLOGY
DYNJ906731M Open, Classified |
OJF | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
CHN GYN ONCOLOGY
DYNJ906731K
DYNJ906731L
DYNJ906731N
DAVINCI PROSTATECTOMY
DYNJG901002A
DYNJG901002B
DYNJG901002C
Open, Classified |
OHD | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
GENERAL DAVINCI
DYNJG901004C
LAP CHOLE
DYNJ88071
ROBOTIC PACK
DYNJ50474F Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
HERNANDEZ DAVINCI ACC BUNDLE M
DYNJ911258
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116I
ROBOTIC CHEST
DYNJ910997
DYNJ910997A
RR-DAVINCI Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135
LAP CHOLE
DYNJ911660
LAP NISSEN
DYNJ911560
UROLOGY LAPAROSCOPIC - 51638
DYNJ908720A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) SPINAL CDS, Medline Product Number/SKU CDS940087AM;
2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C;
3) FEM POP PACK-LF, Medline Product Nu Open, Classified |
OJH | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D Open, Classified |
OJK | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A;
2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M. Open, Classified |
OJG | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PA Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K;
2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J;
3) CV BASIN PACK-LF, Medl Open, Classified |
KDD | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC;
2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) EAR, Medline product number/SKU DYNJ909020B;
2) EAR, Medline product number/SKU DYNJ909020A;
3) CAROTID PACK, Medline product number/SKU DYNJ42922C Open, Classified |
OGR | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D Open, Classified |
OFG | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J;
2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G;
3) AV FISTULA, Open, Classified |
OFF | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) OPEN HEART CDS, Medline product number/SKU CDS840094R;
2) OPEN HEART CDS, Medline product number/SKU CDS840171AG;
3) MHC AV FISTULA, Medline produc Open, Classified |
OEZ | None listed |
| Oct 15, 2026 | Medline Industries, LP 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I;
2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N;
3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Open, Classified |
OES | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D Open, Classified |
OEQ | None listed |
| Oct 5, 2026 | Medline Industries, LP Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS Open, Classified |
ITJ | None listed |
| Oct 5, 2026 | Medline Industries, LP Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XW Open, Classified |
ITJ | None listed |
| Oct 1, 2026 | Medline Industries, LP Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories
MDR107000P BED, MANUAL, MEDLITE Open, Classified |
FNJ | None listed |
| Oct 1, 2026 | Medline Industries, LP Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants:
MDR510094 PENDANT F/ MDR107002E
MDR520094 PENDANT F/ MDR107003E
MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E B Open, Classified |
LLI | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197;
2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001;
3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O;
4) SLUH Open, Classified |
OJH | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I;
2) NEURO PACK-LF, Catalog Number: DYNJ41246F;
3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A;
4) MAJOR NEURO Open, Classified |
OJG | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;
2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q;
3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R;
4) S Open, Classified |
LRO | K213481 |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR PACK, Catalog Number: DYNJ81325A Open, Classified |
FDE | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PEDS SINUS PACK, Catalog Number: DYNJ02516G;
2) SINUS PACK-LF, Catalog Number: DYNJ0342705J;
3) NASAL-LF, Catalog Number: DYNJ40094G;
4) ENT PACK, Catalog Number: DYNJ5 Open, Classified |
OGR | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes.
SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F. Open, Classified |
OGR | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F. Open, Classified |
LRO | K213481 |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
CATARACT PACK
DYNJ59881A Open, Classified |
OJK | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MYRINGOTOMY PACK-LF
DYNJ59097A Open, Classified |
LRO | K213481 |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MINOR PACK
DYNJ58421A
SPRINGHILL MINOR PACK
DYNJ40734F Open, Classified |
FDE | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
ANESTHESIA PAIN PK LEAGUE
DYNJ67925A Open, Classified |
OFT | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDB3086D, Catalog Number: DYNDB3086D;
2) DYNDB3100, Catalog Number: DYNDB3100;
3) DYNDH1619A, Catalog Number: DYNDH1619A;
4) DYNDH1620A, Catalog Number: DYNDH1620A;
Open, Classified |
OIB | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDH1193, Catalog Number: DYNDH1193;
2) DYNDH1487A, Catalog Number: DYNDH1487A Open, Classified |
MCY | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYKM1000B, Catalog Number: DYKM1000B;
2) DYKM2187A, Catalog Number: DYKM2187A Open, Classified |
LRS | None listed |
Newest 50 of 723.