Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV)…
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component…
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the…
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
About the 2020 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.