95,025 total recalls in our database
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Intuitive Surgical
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Siemens Healthcare Diagnostics
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
Elekta Limited
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Distributed to the field without having completed design history files or design transfer activities
Siemens Healthcare Diagnostics
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Becton, Dickinson and Company, BD Biosciences
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Unknown Manufacturer
The recalled heat detectors can fail to activate in reaction to rising temperatures, posing a risk of failure to alert consumers to a fire.
The HON Company LLC, of Muscatine, Iowa
The chair's back can break, posing fall and injury hazards to the user.
Unknown Manufacturer
The charging cable can overheat and partially melt, posing a burn hazard.
Rexair LLC, of Troy, Mich.
The circuit board on the vacuum can spark, posing fire and burn hazards.
Unknown Manufacturer
The teething spoon can break in a child's mouth when being used as a teether, posing a choking hazard to infants.