FDA recall Z-3147-2026

Bayer Medical Care, Inc. · Class II · device

Product

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-07-31
Report date
2026-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianola, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3147-2026