95,025 total recalls in our database
OraSure Technologies
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Potential Endotoxin Contamination
Potential Endotoxin Contamination
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Globus Medical
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Unknown Manufacturer
The tape used to contain wire components within the lamps case housing can overheat and melt, posing a burn hazard.
Unknown Manufacturer
The chair's post can separate from base, posing a fall hazard to the user.
Indiana Mills & Manufacturing, Inc., of Westfield, Ind.
The harness can be missing stitching, posing an injury hazard to the occupant by failing to properly restrain them in the event of a crash.
Calmer Solutions, of United Kingdom
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Mystic Moments UK, of United Kingdom
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.