🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
All Recalls
95,018 total recalls in our database
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
IMPRIS Imaging
🏥 Medical Devices Class I - Dangerous
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Due to incomplete seals in the pouch which provide the sterile barrier.
BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
🏥 Medical Devices Class I - Dangerous
Potential for contamination with cotton fibers.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
ICU Medical
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Canon Medical System, USA
🏥 Medical Devices Class I - Dangerous
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Theater
🏥 Medical Devices Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Theater
🏥 Medical Devices Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.