Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
All Recalls
95,025 total recalls in our database
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
Eight Medical International BV
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Merit Medical Systems
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
OxyMask O2 Adult REF OM-1125-14
Southmedic
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
CooperVision
Misaligned placement of an axis mark can cause the patient to experience blurred vision