ClearanceBrief
510(k) K213481 ยท LRO General Surgery Tray

Medline General Surgery Tray

ApplicantMedline Industries, Inc., Northfiled IL, US
DecisionSubstantially Equivalent, May 24, 2022
ReceivedOct 29, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K213481

DateFirm and productCodeLinked 510(k)
Sep 24, 2026Medline 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
LRONone listed
Sep 18, 2026Medline Industries, LP
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
Open, Classified
LRONone listed
Sep 16, 2026Medline Industries, LP
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Open, Classified
LRONone listed
Sep 11, 2026Medline Industries, LP
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Open, Classified
LRONone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4)
Open, Classified
LRONone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690
Open, Classified
LRONone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAV
Open, Classified
LRONone listed
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYR
Open, Classified
LRONone listed
Jul 23, 2026Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Open, Classified
LRONone listed
Jul 22, 2026Medline Industries, LP
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Open, Classified
LRONone listed
Jul 22, 2026Medline Industries, LP
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Open, Classified
OHMNone listed
Jul 22, 2026Medline Industries, LP
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, M
Open, Classified
OJHNone listed
Jul 15, 2026Medline Industries, LP
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Open, Classified
LRONone listed
Jul 8, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS
Open, Classified
LRONone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTI
Open, Classified
LRONone listed
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
Open, Classified
LRONone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATR
Open, Classified
LRONone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
Open, Classified
LRONone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B
Open, Classified
LRONone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Open, Classified
LRONone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I
Open, Classified
LRONone listed
May 28, 2026Medline Industries, LP
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA
Open, Classified
LRONone listed
May 7, 2026Medline Industries, LP
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model
Open, Classified
LRONone listed
Apr 30, 2026Medline Industries, LP
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Ki
Open, Classified
LRONone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK
Open, Classified
LRONone listed
Apr 16, 2026Medline Industries, LP
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Open, Classified
LRONone listed
Apr 1, 2026Medline Industries, LP
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750
Open, Classified
LRONone listed
Feb 24, 2026Medline Industries, LP
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Open, Classified
LRONone listed
Feb 9, 2026Medline Industries, LP
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDI
Open, Classified
LRONone listed
Nov 13, 2025Medline Industries, LP
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
Open, Classified
LRONone listed
Oct 10, 2025Medline Industries, LP
Medline Adult Anesthesia Set, REF DYNJ39985G
Open, Classified
LRONone listed
Sep 26, 2025Medline Industries, LP
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Open, Classified
LRONone listed
Aug 27, 2025MEDLINE INDUSTRIES, LP - Northfield
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of compo
Open, Classified
LRONone listed
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYN
Open, Classified
LRONone listed
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Open, Classified
OJGNone listed
Apr 10, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RE
Open, Classified
LRONone listed
Mar 14, 2025MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
Open, Classified
LRONone listed
Feb 19, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Open, Classified
LRONone listed
Jan 29, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Open, Classified
LRONone listed
Jan 29, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUND
Open, Classified
LRONone listed
Jan 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Open, Classified
LRONone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
See DocMan
Open, Classified
LRONone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE HEART CABG CDS, REF CDS983376R
Open, Classified
LRONone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Numbe
Open, Classified
LRONone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4)
Open, Classified
LRONone listed
Aug 27, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Open, Classified
LRONone listed
Aug 7, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Open, Classified
LRONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.