Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–105 of 105 recalls
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard.…
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard.…