9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
IMPRIS Imaging
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.
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
Class I - Dangerous
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential for contamination with cotton fibers.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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)
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)
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
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.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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)
Class I - Dangerous
Product lacks 510(k) clearance.