190 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.
FDA Enforcement
Class II
·Ongoing·Medline Industries, Inc.·July 24, 2019
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·December 26, 2012
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Major Vascular CDS Convenience Kit
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·December 22, 2021
Bedside PICC CDS Convenience Kit
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·December 22, 2021
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·October 26, 2022
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
MEDLINE HEART CABG CDS, REF CDS983376R
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 23, 2024
Cardiac Insulation Pad, OPEN HEART CDS
FDA Enforcement
Class II
·Terminated·Medline Industries, Inc.·September 12, 2018
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ; 6) PROCEDURE PACK-LF , Pack Number 00-401585M ; 7) PTCA PACK , Pack Number 00-401800F ; 8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ; 9) PICC LINE TRAY, Pack Number 00-401993N ; 10) ARTERIOGRAM TRAY, Pack Number 00-402001S ; 11) CARDIAC CATH PACK , Pack Number 00-500502L ; 12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N; 13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O; 14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P; 15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672; 16) KIT ANGIO CSTM, Pack Number 135169; 17) KIT NEURO 2-UIC, Pack Number 138557; 18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ; 19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356; 20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1; 21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ; 22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ; 23) PROCEDURAL ACC KIT, Pack Number 20060921 ; 24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ; 25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ; 26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ; 27) BASIC PROCEDURE PACK, Pack Number 7790 ; 28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ; 29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ; 30) PROCEDURE PACK, RF, Pack Number 7795 ; 31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ; 32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ; 33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ; 34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ; 35) NEONATAL DRAWER 6 , Pack Number ACC010653; 36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A; 37) RADIAL TRAY , Pack Number AM140A ; 38) RADIAL TRAY , Pack Number AM140B ; 39) SET UP TRAY , Pack Number AM235A ; 40) PACK SET UP , Pack Number AM235B ; 41) HEAD & NECK TRAY, Pack Number AM310A ; 42) 18GX6 FEMORAL ART MAX BARRIER KIT, Pack Number ART1230; 43) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 44) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 45) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110; 47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686; 48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710; 49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ; 50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ; 51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ; 52) CYSTO PROCEDURE , Pack Number CDS760062O ; 53) NEURO CDS , Pack Number CDS780056M ; 54) SHUNT CDS-LF, Pack Number CDS780103J ; 55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ; 56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ; 57) UVALDE C-SECTION CDS, Pack Number CDS820116D ; 58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ; 59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ; 60) AAA CDS , Pack Number CDS840076AB; 61) AAA CDS , Pack Number CDS840076X ; 62) AAA CDS , Pack Number CDS840076Y ; 63) OFF PUMP CABG CDS , Pack Number CDS840087AA; 64) OFF PUMP CABG CDS , Pack Number CDS840087AC; 65) OPEN HEART, Pack Number CDS840150Q ; 66) VALVE PACK, Pack Number CDS840187R ; 67) AV FISTULA PACK , Pack Number CDS840188L ; 68) MAJOR VASCULAR PACK , Pack Number CDS840195S ; 69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ; 70) FETOSCOPY CDS-LF, Pack Number CDS840215N ; 71) MAJOR VASCULAR-LF , Pack Number CDS840232J ; 72) AVF-LF, Pack Number CDS840233D ; 73) AVF-LF, Pack Number CDS840233F ; 74) AVF-LF, Pack Number CDS840233G ; 75) GENERAL AAA #11-RF, Pack Number CDS840261AA; 76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ; 77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ; 78) THOROCOTOMY , Pack Number CDS840354N ; 79) THOROCOTOMY , Pack Number CDS840354O ; 80) THORO
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
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 CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 8, 2023
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF CDS920080T; 8) GENERAL LAPAROSCOPY, REF CDS930027V; 9) GENERAL LAPAROSCOPY, REF CDS930027X; 10) GENERAL MINOR CDS, REF CDS980246V; 11) BASIC CDS, REF CDS982936V; 12) MAJOR ABDOMINAL CDS, REF CDS983759L; 13) GENERAL SURGERY CDS, REF CDS983914L; 14) GENERAL LAP, REF CDS984251N; 15) ACH MINOR PROCEDURE, REF CDS985451G; 16) SCOPE LAP THOR PACK, REF DYNJ00210N; 17) MAJOR LAPAROTOMY PACK, REF DYNJ00387P; 18) MAJOR ABDOMINAL HARPER PACK-LF, REF DYNJ0160657D; 19) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 20) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 21) MAJOR PACK-LF, REF DYNJ0386381L; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 23) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 24) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 25) MAJOR LAPAROTOMY PACK, REF DYNJ20819M; 26) MAJOR ABDOMINAL, REF DYNJ23429G; 27) MINI LAPAROTOMY #16-RF, REF DYNJ27322S; 28) MINI LAPAROTOMY #16-RF, REF DYNJ27322T; 29) TN LAPAROTOMY PACK-LF, REF DYNJ34206I; 30) LAPAROTOMY, REF DYNJ34424N; 31) COREWELL TSC- LAP PACK-LF, REF DYNJ37100I; 32) GENERAL LAP PACK, REF DYNJ38223C; 33) LAP CHOLE PACK, REF DYNJ38228C; 34) MINOR PACK, REF DYNJ41418I; 35) GENERAL PACK-LF, REF DYNJ43213J; 36) HERNIA PACK, REF DYNJ44683L; 37) GENERAL ABDOMINAL, REF DYNJ44870J; 38) LAP CHOLE PACK, REF DYNJ44873I; 39) LAP RENAL PACK, REF DYNJ44875O; 40) MAJOR LAPAROTOMY, REF DYNJ45334G; 41) MAJOR LAPAROTOMY, REF DYNJ45334J; 42) MINOR PROCEDURE, REF DYNJ45336J; 43) MINOR PROCEDURE PACK, REF DYNJ47057D; 44) MINOR PROCEDURE PACK, REF DYNJ47057F; 45) MAJOR BASIC PACK (MBGSE)227-LF, REF DYNJ47696J; 46) LAP CHOLE PACK, REF DYNJ48092G; 47) LAPAROTOMY PACK, REF DYNJ48093F; 48) ISS GENERAL PACK, REF DYNJ48921I; 49) MINOR UROLOGY PACK, REF DYNJ49310F; 50) HERNIA SGM PACK-LF, REF DYNJ51434B; 51) MINOR GENERAL PACK, REF DYNJ52329C; 52) MINOR GENERAL PACK, REF DYNJ52329D; 53) MINOR GENERAL PACK, REF DYNJ52329F; 54) MINOR LAPAROTOMY PACK-LF, REF DYNJ52863D; 55) MINOR GENERAL PACK, REF DYNJ53036G; 56) MINOR GENERAL PACK, REF DYNJ53036I; 57) IPP PENILE PROSTHESIS PACK, REF DYNJ58061J; 58) MAJOR LAPAROTOMY PACK, REF DYNJ58561D; 59) MAJOR LAPAROTOMY PACK, REF DYNJ58561F; 60) MINOR PACK, REF DYNJ58562D; 61) MINOR PACK, REF DYNJ58562F; 62) MINOR GENERAL PACK, REF DYNJ59358D; 63) PACK HERNIA INGUINAL, REF DYNJ60145B; 64) PK CUST MAJOR ST MICHAEL, REF DYNJ60782B; 65) CENTRACARE PLAZA-LAP CHOLE PK, REF DYNJ61620C; 66) MINOR GEN PACK, REF DYNJ61661A; 67) SLCH MAJOR GENERAL PACK, REF DYNJ61666A; 68) DAVINCI PROSTATE PACK, REF DYNJ61711B; 69) THORACIC PACK, REF DYNJ62015C; etc
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025