Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 277–288 of 386 recalls
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probabili…
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Due to defects (bubbles/voids) identified during standard finished goods testing
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing fa…
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.