95,114 total recalls in our database
Cardinal Health 200
The feeding spike sets may leak at the interface of the tube and spike connector.
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Coltene Whaledent
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Cardinal Health 200
The feeding spike sets may leak at the interface of the tube and spike connector.
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Thomas Scientific
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Roche Diagnostics Operations
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
The product may be mislabeled.
Siemens Healthcare Diagnostics
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
Siemens Healthcare Diagnostics
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Medicrea International
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
Potential for cleaning solution intrusion into endoscope
Coltene Whaledent
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Herobility AB, of Sweden
The Eco Baby Spoon and Fork and Eco Feeding Spoon can break into small pieces, posing a choking hazard.