Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 118 recalls
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.