Device recall

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

FDA recall source

Recall number

Z-3147-2026

Event id

99698

Status

Ongoing

FDA classification

Class II

Recalling firm

Bayer Medical Care, Inc.

Report date

Sep 23, 2026

Posted

Sep 11, 2026

Initiated

Jul 31, 2026

Center classification date

Sep 11, 2026

Product code

DXT

Device type

Injector And Syringe, Angiographic

Reason

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

Root cause

Employee error

Quantity

27800 kits (556 boxes)

Code info

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

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K182273

Location

Indianola, PA, United States