An FDA-recorded root-cause determination. The FDA lists 92 recalls with this root cause since 2025, 14 of them Class I (most serious). Most recent report: Aug 12, 2026.
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.
This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in c…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Due to unsealed portions of pouches.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.