Class IOngoingZ-0109-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025
Recalls: Package design/selection
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 68 recalls
Class IIOngoingZ-1875-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160648
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-1874-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160556
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-1873-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160341
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-1872-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160333
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-1871-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160325
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-1870-2025
Cardinal Health 200, LLC recalls Catalog No. 8888160119
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Cardinal Health 200, L…ILJun 4, 2025
Class IIOngoingZ-0900-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Varicam Millennium VG Discovery VH
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE MEDICAL SYSTEMS ISR…Jan 22, 2025
Class IIOngoingZ-0899-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia II Hawkeye 4
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE MEDICAL SYSTEMS ISR…Jan 22, 2025
Class IIOngoingZ-0898-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia I Hawkeye 1
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE MEDICAL SYSTEMS ISR…Jan 22, 2025
Class IIOngoingZ-0897-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia II
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE MEDICAL SYSTEMS ISR…Jan 22, 2025
Class IIOngoingZ-0896-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Optima NM/CT 640
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE MEDICAL SYSTEMS ISR…Jan 22, 2025