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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

Baxter Healthcare

Class I - Dangerous

Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

May 19, 2023 Other Medical Devices Nationwide View Details →

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633

Randox Laboratories

Class I - Dangerous

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

May 4, 2023 Diagnostic Equipment View Details →

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

Baxter Healthcare

Class I - Dangerous

Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

May 19, 2023 Other Medical Devices Nationwide View Details →