510(k) K213481 ยท LRO General Surgery Tray
Medline General Surgery Tray
| Applicant | Medline Industries, Inc., Northfiled IL, US |
| Decision | Substantially Equivalent, May 24, 2022 |
| Received | Oct 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | 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 | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MYRINGOTOMY PACK-LF
DYNJ59097A Open, Classified |
LRO | None listed |
| Sep 11, 2026 | Medline Industries, LP Medline Convenience Kit:
OPEN HEART A PACK, Product Number DYNJ43008N Open, Classified |
LRO | None listed |
| Aug 31, 2026 | Medline 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 |
LRO | None listed |
| Aug 31, 2026 | Medline 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 |
LRO | None listed |
| Aug 26, 2026 | Medline 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 |
LRO | None listed |
| Aug 21, 2026 | Medline 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 |
LRO | None listed |
| Jul 23, 2026 | Medline Industries, LP MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N Open, Classified |
LRO | None listed |
| Jul 22, 2026 | Medline Industries, LP MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G Open, Classified |
LRO | None listed |
| Jul 22, 2026 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) C-SECTION, Medline SKU DYNJ910835;
2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits Open, Classified |
OHM | None listed |
| Jul 22, 2026 | Medline 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 |
OJH | None listed |
| Jul 15, 2026 | Medline Industries, LP Medline Kits containing Zimmer Biomet mixing bowls and spatulas
TOTAL KNEE PACK
DYNJT6267 Open, Classified |
LRO | None listed |
| Jul 8, 2026 | Medline 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 |
LRO | None listed |
| Jun 29, 2026 | Medline 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 |
LRO | None listed |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
OPEN HEART
DYNJ909090B
OPEN HEART CDS QVH
CDS982523M Open, Classified |
LRO | None listed |
| Jun 25, 2026 | Medline 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 |
LRO | None listed |
| Jun 17, 2026 | Medline 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 |
LRO | None listed |
| Jun 12, 2026 | Medline 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 |
LRO | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
DRIVELINE MANAGEMENT KIT
EBSI1688
PORT DRESSING CHANGE KIT
EBSI1328A Open, Classified |
LRO | None listed |
| Jun 12, 2026 | Medline 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 |
LRO | None listed |
| May 28, 2026 | Medline 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 |
LRO | None listed |
| May 7, 2026 | Medline 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 |
LRO | None listed |
| Apr 30, 2026 | Medline 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 |
LRO | None listed |
| Apr 17, 2026 | Medline 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 |
LRO | None listed |
| Apr 16, 2026 | Medline Industries, LP CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F Open, Classified |
LRO | None listed |
| Apr 1, 2026 | Medline 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 |
LRO | None listed |
| Feb 24, 2026 | Medline Industries, LP Medline kits containing Tego Connectors
Medline APHERESIS SUBQPORT ACCESS KIT
SKU DYNDA2705
Medline CENTRAL LINE INSERTION
SKU DYNJ63347A Open, Classified |
LRO | None listed |
| Feb 9, 2026 | Medline 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 |
LRO | None listed |
| Nov 13, 2025 | Medline Industries, LP Convenience Kits:
DYNJ901048N ORTHO SPINE ST CLAIR
DYNJ909123F UROLOGY MINOR
DYNJ909132F SET UP
DYNJ909308D HIP PINNING Open, Classified |
LRO | None listed |
| Oct 10, 2025 | Medline Industries, LP Medline Adult Anesthesia Set, REF DYNJ39985G Open, Classified |
LRO | None listed |
| Sep 26, 2025 | Medline Industries, LP Sterile Medline Convenience Kits:
1) MAJOR PACK L-F, Model Number: DYNJ0382730O;
2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B Open, Classified |
LRO | None listed |
| Aug 27, 2025 | MEDLINE 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 |
LRO | None listed |
| May 31, 2025 | MEDLINE 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 |
LRO | None listed |
| May 31, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits containing Codman Disposable Perforator 14 mm:
CRANIOTOMY, SKU DYNJ35349C Open, Classified |
OJG | None listed |
| Apr 10, 2025 | MEDLINE 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 |
LRO | None listed |
| Mar 14, 2025 | MEDLINE 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 |
LRO | None listed |
| Feb 19, 2025 | MEDLINE 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 |
LRO | None listed |
| Jan 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating. Open, Classified |
LRO | None listed |
| Jan 29, 2025 | MEDLINE 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 |
LRO | None listed |
| Jan 28, 2025 | MEDLINE 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 |
LRO | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield See DocMan Open, Classified |
LRO | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE HEART CABG CDS, REF CDS983376R Open, Classified |
LRO | None listed |
| Aug 28, 2024 | MEDLINE 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 |
LRO | None listed |
| Aug 28, 2024 | MEDLINE 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 |
LRO | None listed |
| Aug 27, 2024 | MEDLINE 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 |
LRO | None listed |
| Aug 7, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A Open, Classified |
LRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.