🏥 Medical Devices Class I - Dangerous
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
All Recalls
95,050 total recalls in our database
🏥 Medical Devices Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Johnson & Johnson Vision Care
🏥 Medical Devices Class I - Dangerous
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
🏥 Medical Devices Class I - Dangerous
DualStop Caps defect causing leaks in affected product
🏥 Medical Devices Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
ulrich medical USA
🏥 Medical Devices Class I - Dangerous
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
🏥 Medical Devices Class I - Dangerous
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
🏥 Medical Devices Class I - Dangerous
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
🏥 Medical Devices Class I - Dangerous
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
🏥 Medical Devices Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
🏥 Medical Devices Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
🏥 Medical Devices Class I - Dangerous
DualStop Caps defect causing leaks in affected product
🏥 Medical Devices Class I - Dangerous
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
🏥 Medical Devices Class I - Dangerous
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
🏥 Medical Devices Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Azurion FlexArm, 722079
Philips North America
🏥 Medical Devices Class I - Dangerous
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
🏥 Medical Devices Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Arrow International
🏥 Medical Devices Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct