🏥 Medical Devices • 15,203 recalls
CareFusion 303
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Siemens Medical Solutions USA
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
American Contract Systems
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
American Contract Systems
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
American Contract Systems
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
CareFusion 303
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
CareFusion 303
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Siemens Medical Solutions USA
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
CareFusion 303
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
LEICA BIOSYSTEMS NUSSLOCH GMBH
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
CareFusion 303
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
American Contract Systems
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Angiodynamics
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
EVIDENT SCIENTIFIC
A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Angiodynamics
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Medtronic Perfusion Systems
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.