66 results
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20ms
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Sources: EU EUDAMED, US FDA
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
FDA Recall
Open, Classified
·Product code JOL·January 7, 2026
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
FDA Recall
Open, Classified
·Product code JOL·January 7, 2026
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OXQ·May 18, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number: DT22065; h. VA MAINTENANCE PACK, Model Number: EBSI1382;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OXQ·May 15, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRP·May 18, 2023
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
FDA Recall
Open, Classified
·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code JBP·October 20, 2025
Allia IGS 5 Pulse angiographic X-ray system
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code OWB·April 20, 2026
Allia IGS 3 Pulse angiographic X-ray system
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code OWB·April 20, 2026
Allia Moveo angiographic X-ray system
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code OWB·April 20, 2026
Allia IGS Pulse angiographic X-ray system
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code OWB·April 20, 2026
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·March 5, 2024
Allia IGS 7 Pulse angiographic X-ray system
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code OWB·April 20, 2026
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
FDA Recall
Open, Classified
·Moberg Research, Inc.·Product code OMA·February 20, 2023
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
FDA Recall
Open, Classified
·Becton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·April 21, 2025
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
FDA Recall
Open, Classified
·NxStage Medical Inc·Product code KPO·May 14, 2024
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
FDA Recall
Open, Classified
·Abbott Laboratories, Inc·Product code MZA·July 12, 2021
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 DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C-SECTION DYNJ909099F DAVINCI PROSTATE PACK DYNJ61711C DEPAUL FOOT & ANKLE-LF DYNJ20010L DIEP PACK DYNJ64964J DYNJ43210K DYNJ61787F DYNJ87065 EAR CUSTOM PACK DYNJ82564A ENT FREE FLAP PACK SAFETY DYNJ54720D EP PACEMAKER SAFETY #1 DYNJ54722F EPCH EXTREMITY PACK DYNJ83095B EXTREMITY PACK DYNJ32934F EXTREMITY PACK-LF DYNJ68935B FISTULA PACK DYNJ66502B GENDER AFFIRMING SURGERY DYNJ66252F GYN LAPAROSCOPY PACK AHSC DYNJT8381 HAND PACK WATCHMAKER-LF DYNJ34580D HEAD & NECK PACK-LF DYNJ0282388T DYNJ88308 HIP SCOPE DYNJ907120D KNEE ARTHRO PACK DYNJ58404F KNEE ARTHROSCOPY PACK DYNJ84740A LAMI OVERHEAD PACK DYNJ46531Q LAMINECTOMY NEURO MPH DYNJT5271 LAMINECTOMY PACK DYNJ68785D LAP APPY PACK DYNJT6005 LAP CHOLE PACK DYNJ82087A LEVY PACK DYNJ83939C MAJOR LAP VCH DYNJ39217P MAJOR NEURO PACK-LF DYNJ0578916AA MAJOR PACK DYNJ58528J MINOR GEN PACK DYNJ61661B MINOR LAPAROTOMY PACK-LF DYNJ0753436P MINOR PACK DYNJ54968B NEURO PACK DYNJ67628D NEURO SHUNT PACK-LF DYNJ0578815W OMFS PACK DYNJ54400C OPEN HEART PACK DYNJT5008 OPEN HEART-LF DYNJ48260F OPEN LAPAROTOMY PACK DYNJ39247I DYNJ39247J PACEMAKER PACK DYNJ31461I DYNJ61411C PACK,ORTHO FLIP DYNJ65471B PED OPEN HEART PACK DYNJ45373G PLASTIC PACK DYNJ82495D PLASTICS PK - NO SYR DYNJ62433F PODIATRY PACK OP7809M PPE BUNDLE KIT DT13351A PROSTATE ROBOTIC PACK DYNJ84120C RADIAL ART LINE INSERTION ARTNC234 ROBOTIC GENERAL WHH DYNJT5376 ROBOTIC PACK DYNJ47978G RR-SPINE PACK DYNJ62643B SHOULDER ARTH PACK DYNJ58410D SHOULDER ARTHROSCOPY PACK DYNJ54477C DYNJT8391 SHOULDER PACK DYNJ61052B DYNJT3266 SHOULDER PACK-LF DYNJ0122428K PHS656414I SPINE PACK DYNJ64949C DYNJ83649B SPINE SHOULDER PACK DYNJ47104D STERILE ACCESS KIT DYNDA2664 TOTAL KNEE PACK DYNJ84741B TUBAL PACK DYNJ68253F UNIVERSAL PACK DYNJ83246B VA TAMPA GENERAL ROBOTIC PACK DYNJT6993 W.C. MINOR LAPAROTOMY PK-LF DYNJ0509186J ZALE OTOLOGY CDS CDS983181G
FDA Recall
Open, Classified
·Product code LRO·April 27, 2026
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRP·May 15, 2023
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 Recall
Open, Classified
·Product code LRO·January 7, 2026