Class IIOngoingZ-2261-2026
Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 6088…
Due to customer complaint regarding incorrect display box labeling.
Covidien LLCCOJun 10, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 361–372 of 3,866 recalls
Class IIOngoingZ-2206-2026
Siemens Medical Solutions USA, Inc recalls ARTIS Icono biplane
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions.…
Siemens Medical Soluti…PAJun 10, 2026
Class IIOngoingZ-2205-2026
Siemens Medical Solutions USA, Inc recalls ARTIS pheno
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions.…
Siemens Medical Soluti…PAJun 10, 2026
Class IIOngoingZ-2260-2026
Medline Industries, LP recalls Medline medical convenience kit labeled as EYE TRAY-LF
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer L…
Medline Industries, LPILJun 3, 2026
Class IIOngoingZ-2259-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service.…
PHILIPS MEDICAL SYSTEM…Jun 3, 2026
Class IIOngoingZ-2258-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service.…
PHILIPS MEDICAL SYSTEM…Jun 3, 2026
Class IIOngoingZ-2247-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare ApexPro v6.0 eDelivery Software
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026
Class IIOngoingZ-2246-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026
Class IIOngoingZ-2245-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026
Class IIOngoingZ-2244-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026
Class IIOngoingZ-2243-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable b…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026
Class IIOngoingZ-2242-2026
GE Medical Systems Information Technologies Inc recalls GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWOR…
GE Medical Systems Inf…WIJun 3, 2026