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

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2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

FDA Recall
Open, Classified ·Medtronic Inc.·Product code NVZ·July 11, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·November 15, 2023

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OEZ·June 11, 2024

Halyard EP PACK - Medical convenience kits Model Number: VANW018-06

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

MEDLINE OPEN HEART PACK, REF DYNJ66216C

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·August 28, 2024

(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·October 15, 2024

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

FDA Recall
Open, Classified ·American Contract Systems Inc·Product code OEZ·February 6, 2025

AV FISTULA , Model No UTAV77T

FDA Recall
Open, Classified ·American Contract Systems Inc·Product code OEZ·February 6, 2025

Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code OEZ·May 29, 2024

FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·November 6, 2024

Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OEZ·April 21, 2026

CARDIAC ROBOT PACK. Medical convenience kit.

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·June 11, 2025

Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03

FDA Recall
Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

FDA Recall
Open, Classified ·American Contract Systems Inc·Product code OEZ·February 6, 2025

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·May 15, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·May 15, 2023