All Recalls

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

The device was assembled with the incorrect exhalation port which can cause gas leakage.

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

The expiration date on labeling is incorrect.

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

The lithium-ion battery system can overheat, posing a fire hazard.