13 results · 18ms · Sources: EU EUDAMED, US FDA

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NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

FDA Recall
Open, Classified ·Ansell Healthcare Products LLC·Product code KGO·August 3, 2023

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

FDA Recall
Open, Classified ·Ansell Healthcare Products LLC·Product code KGO·August 3, 2023

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

FDA Recall
Open, Classified ·Ansell Healthcare Products LLC·Product code KGO·February 19, 2022

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NKE·December 12, 2024

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 12, 2024

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NKE·December 12, 2024

ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 12, 2024

ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 12, 2024

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 12, 2024

Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

FDA Recall
Open, Classified ·Product code KDD·March 21, 2019

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

FDA Recall
Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FDE·August 16, 2023

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 Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·April 8, 2024