Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,609–1,620 of 2,088 recalls
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitati…
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on sy…
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top…
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minute…
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing.…
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing.…
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing.…