🏥 Medical Devices Class I - Dangerous
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
All Recalls
95,094 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Compromised sterility due to breach of barrier
🏥 Medical Devices Class I - Dangerous
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Covidien
🏥 Medical Devices Class I - Dangerous
Compromised sterility due to breach of barrier
🏥 Medical Devices Class I - Dangerous
Compromised sterility due to breach of barrier
🏥 Medical Devices Class I - Dangerous
Compromised sterility due to breach of barrier
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Natus Medical Incorporated
🏥 Medical Devices Class I - Dangerous
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
🏥 Medical Devices Class I - Dangerous
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
🏥 Medical Devices Class I - Dangerous
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
🏥 Medical Devices Class I - Dangerous
Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Fujifilm Medical Systems U.S.A.
🏥 Medical Devices Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
🏥 Medical Devices Class I - Dangerous
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
🏥 Medical Devices Class I - Dangerous
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
🏥 Medical Devices Class I - Dangerous
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
🏥 Medical Devices Class I - Dangerous
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
Sleds
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The front handle bar assembly can break, posing a crash hazard.
Focus Spine bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bicycle seatstay or linkage component parts used to connect the seat tube and rear axle dropouts can be incorrectly sized which can cause the frame to collapse, posing a fall hazard to the rider.
Ceramic mugs
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The mug's handle can break, posing a burn or laceration hazard to consumers.