Medical device recalls

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Gauze sponges contained in custom kits may be flaking or fraying.

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.

Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.

There is a potential software error during programming.

There is a potential software error during programming.

There is a potential software error during programming.

There is a potential software error during programming.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.