An FDA-recorded root-cause determination. The FDA lists 30 recalls with this root cause since 2025, 4 of them Class I (most serious). Most recent report: Oct 7, 2026.
Due to blood-to-glycol leak in the heat exchanger.
Due to blood-to-glycol leak in the heat exchanger.
The proximal thread depth of the spinal device is out of design specification.
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mat…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.