Category

Cardiac Devices Recalls

958 cardiac devices recalls on record from CPSC, FDA, and USDA.

958 recalls
CriticalFDA
Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL M...
Cardiac Devices·685,776 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU...
Cardiac Devices·4,016 affected·Mar 19, 2026
CriticalFDA
Avid Medical, Inc.
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Cardiac Devices·6,956 affected·Mar 13, 2026
CriticalFDA
Avid Medical, Inc.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Cardiac Devices·180 affected·Mar 13, 2026
CriticalFDA
Avid Medical, Inc.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Cardiac Devices·222 affected·Mar 13, 2026
CriticalFDA
Avid Medical, Inc.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Cardiac Devices·2,932 affected·Mar 13, 2026
High RiskFDA
Medtronic, Inc.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Cardiac Devices·77,510 affected·Mar 11, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF D...
Cardiac Devices·270,311 affected·Feb 27, 2026
CriticalFDA
Medline Industries, Lp
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as fo...
Cardiac Devices·17,902 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Cardiac Devices·270,311 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE P...
Cardiac Devices·270,311 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Cardiac Devices·39 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DY...
Cardiac Devices·160,883 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026...
Cardiac Devices·19,189 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDUR...
Cardiac Devices·2,894 affected·Jan 30, 2026
High RiskFDA
Physio-control, Inc.
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalo...
Cardiac Devices·16,499 affected·Jan 21, 2026
High RiskFDA
Medline Industries, Lp
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS8400...
Cardiac Devices·51,061 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYK...
Cardiac Devices·4,064 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVAS...
Cardiac Devices·39,341 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Cardiac Devices·551 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Cardiac Devices·599 affected·Jan 7, 2026
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm...
Cardiac Devices·364 affected·Dec 24, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) ...
Cardiac Devices·857 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit...
Cardiac Devices·1,928 affected·Dec 12, 2025
CriticalFDA
Medline Industries, Lp
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Cardiac Devices·96,406 affected·Oct 10, 2025
CriticalFDA
Glycar Sa Pty., Ltd.
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Cardiac Devices·18 affected·Oct 9, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1...
Cardiac Devices·10,153 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Cardiac Devices·12 affected·Sep 30, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·28 affected·Sep 12, 2025
High RiskFDA
Philips North America
Cardiac Workstation 5000; Model Number: 860439;
Cardiac Devices·28 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·292 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·64 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·1,386 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·82 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·102 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·3 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·205 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·45 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·15 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·54 affected·Sep 12, 2025
CriticalFDA
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Cardiac Devices·11,810 affected·Sep 10, 2025
CriticalFDA
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Cardiac Devices·3,404 affected·Sep 10, 2025
CriticalFDA
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Cardiac Devices·407 affected·Sep 10, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is...
Cardiac Devices·8 affected·Sep 2, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Cardiac Devices·106,536 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number S702, ALTRUA 2 DR SL Pacemaker
Cardiac Devices·4,055 affected·Aug 20, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Package...
Cardiac Devices·71 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L231, PROPONENT DR EL MRI Pacemaker
Cardiac Devices·63,851 affected·Aug 20, 2025