Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,189–1,200 of 2,908 recalls
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Norm…
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…