ClearanceBrief
Panels › General, Plastic Surgery › Product code LRO · Class 2

General Surgery Tray

Regulation 878.4370

0510(k)s in 12 months (110 all time)
101recalls in 12 months (1,082 all time)
141recalls that name a 510(k)
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Top companies in LRO

DateFirm and productCodeLinked 510(k)
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
LROK213481
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
Open, Classified
LROK213481
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
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
LROK213481
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F C
Open, Classified
LRONone listed
Jun 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Mo
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
LROK213481
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
LROK213481
Jun 12, 2026Medline Industries, LP
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Open, Classified
LROK213481
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
LROK213481
Jun 12, 2026Medline Industries, LP
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUN
Open, Classified
LRONone listed
Jun 11, 2026AVID Medical, Inc.
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Open, Classified
LRONone listed
Jun 3, 2026Windstone Medical Packaging, Inc.
Aligned Medical AMS16835 Fluids Kit RX
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
LROK213481
May 8, 2026Windstone Medical Packaging, Inc.
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Open, Classified
LRONone listed
May 8, 2026Medline Industries, LP
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;
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
LROK213481
K962826
May 6, 2026American Contract Systems Inc
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Open, Classified
LRONone listed
May 6, 2026Medical Action Industries, Inc. 306
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Open, Classified
LRONone listed
May 1, 2026AVID Medical, Inc.
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
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
LROK213481
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
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
LROK213481
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ870
Open, Classified
LRONone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Numbe
Open, Classified
LRONone listed
Apr 16, 2026Medline Industries, LP
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Open, Classified
LROK213481
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS
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
LROK213481
Mar 27, 2026Medline Industries, LP
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
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
LROK213481
Feb 24, 2026Medline Industries, LP
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI431
Open, Classified
LRONone listed
Feb 24, 2026Medline Industries, LP
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Open, Classified
LRONone listed
Feb 20, 2026Medline Industries, LP
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYK
Open, Classified
LROK112666
Feb 17, 2026Medline Industries, LP
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Open, Classified
LRONone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CAR
Open, Classified
LRONone listed
Feb 9, 2026AVID Medical, Inc.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
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
LROK213481
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS
Open, Classified
LRONone listed
Jan 14, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE,
Open, Classified
LRONone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SK
Open, Classified
LRONone listed
Jan 2, 2026AVID Medical, Inc.
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Open, Classified
LRONone listed
Jan 2, 2026AVID Medical, Inc.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Open, Classified
LRONone listed
Jan 2, 2026AVID Medical, Inc.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Open, Classified
LRONone listed
Dec 23, 2025Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom
Open, Classified
LRONone listed
Dec 15, 2025AVID Medical, Inc.
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Open, Classified
LRONone listed
Dec 15, 2025AVID Medical, Inc.
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Open, Classified
LRONone listed
Dec 15, 2025AVID Medical, Inc.
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Open, Classified
LRONone listed
Dec 15, 2025AVID Medical, Inc.
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Open, Classified
LRONone listed
Dec 15, 2025AVID Medical, Inc.
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Open, Classified
LRONone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BAS
Open, Classified
LRONone listed

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