FDA Alerts Highlight Challenges in Managing Medical Device Recalls

Recent FDA alerts reveal the complexities healthcare facilities face in identifying and removing recalled devices.

Sept. 8, 2026

2 min read

Key Highlights

FDA issued serious recall alerts for Boston Scientific and Draeger devices due to safety concerns like fractures and leaks, respectively.
Recalls can involve complex product components embedded within customized kits, complicating removal, and replacement efforts.
Effective recall management depends on accurate item-master data, detailed product tracking, and clear communication among clinical and supply chain teams.

Several FDA device alerts issued Sept. 2–3 highlight the operational complexity of identifying and removing recalled products across healthcare facilities.

Boston Scientific is removing unused Infinion CX spinal cord stimulator leads because mechanical stress may cause fractures or high impedance. The FDA classified the action as its most serious recall type after 1,081 serious injuries were reported, with no deaths.

Draeger also instructed customers to remove certain neonatal VentStar Resus Neo breathing-circuit hoses after cracks were discovered. Leaks or disconnections could result in inadequate ventilation, hypoxia or death, although no serious injuries or deaths had been reported.

A separate action involving AVID Medical illustrates how recalls can spread beyond a single product. The company revised its instructions for IV start kits containing recalled BD ChloraPrep applicators because of potential fungal contamination. Customers must now quarantine and destroy the entire affected kit instead of removing only the applicator.

For healthcare supply chain leaders, the alerts underscore the importance of tracing products at the lot and component levels, especially when recalled items are embedded inside customized procedure kits. Effective responses require accurate item-master data, visibility into kit contents, point-of-use notifications, and clear coordination among supply chain, infection prevention, and clinical departments.