FDAClass IISeptember 23, 2026

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant recall

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

Why was MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Recalling firm
Bayer Medical Care, Inc.
Quantity
27800 kits (556 boxes)
Distribution
US Nationwide distribution.
Recall date
September 23, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls