Official recall notice

FDA DeviceClass IINotable

FDA Recall: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEX

Recall date
2026-09-23
FDA class
Class II

Why it was recalled

Hazard

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Product description

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Affected products

Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;

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