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958 recalls
High RiskFDA
Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) ...
Cardiac Devices·2,109,804 affected·Nov 18, 2024
High RiskFDA
St. Jude Medical
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System mo...
Cardiac Devices·25 affected·Nov 6, 2024
High RiskFDA
Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Cardiac Devices·5 affected·Oct 17, 2024
High RiskFDA
Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Cardiac Devices·1 affected·Oct 17, 2024
High RiskFDA
Abbott Medical
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Cardiac Devices·1 affected·Oct 17, 2024
High RiskFDA
Abbott Medical
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Cardiac Devices·8 affected·Oct 17, 2024
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1...
Cardiac Devices·408 affected·Oct 15, 2024
High RiskFDA
Defibtech, Llc
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DD...
Cardiac Devices·22,294 affected·Oct 14, 2024
High RiskFDA
Baxter Healthcare Corporation
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
Cardiac Devices·2,461 affected·Oct 11, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS8...
Cardiac Devices·30,092 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0...
Cardiac Devices·14,388 affected·Oct 9, 2024
High RiskFDA
Avid Medical, Inc.
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
Cardiac Devices·12 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Cardiac Devices·46 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Cardiac Devices·56 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Cardiac Devices·114 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
Cardiac Devices·288 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Cardiac Devices·33 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Cardiac Devices·6 affected·Sep 20, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive dis...
Cardiac Devices·6 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive displ...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provid...
Cardiac Devices·9 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide p...
Cardiac Devices·161 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display ...
Cardiac Devices·2 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to pro...
Cardiac Devices·58 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive dis...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive displ...
Cardiac Devices·1 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·92 affected·Sep 5, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT,...
Cardiac Devices·2,631 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, ...
Cardiac Devices·22,327 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYN...
Cardiac Devices·1,460 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE OPEN HEART, REF DYNJ904261B
Cardiac Devices·30 affected·Aug 28, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Cardiac Devices·123 affected·Aug 28, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE HEART CABG CDS, REF CDS983376R
Cardiac Devices·15 affected·Aug 28, 2024
High RiskFDA
Physio-control, Inc.
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicat...
Cardiac Devices·3,617 affected·Aug 9, 2024
High RiskFDA
American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit
Cardiac Devices·3 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit
Cardiac Devices·20 affected·Aug 7, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and admin...
Cardiac Devices·3 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnost...
Cardiac Devices·7 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a d...
Cardiac Devices·2 affected·Jul 3, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK10...
Cardiac Devices·1,646 affected·Jun 27, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introd...
Cardiac Devices·55,305 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angi...
Cardiac Devices·103,369 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentes...
Cardiac Devices·72,115 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Man...
Cardiac Devices·188,837 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure...
Cardiac Devices·69 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure K...
Cardiac Devices·168,157 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe ...
Cardiac Devices·13,560 affected·Jun 11, 2024