CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care

Bayer Medical Care is recalling Medrad¿ Stellant Flex Syringe Kit used with Stellant Flex CT Injection System, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;

Quantity recalled27800 kits (556 boxes)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3147-2026
FDA event ID: 99698
Recalling firm: Bayer Medical Care, Indianola, PA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2026
FDA classified: 11 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Syringes & Needles

Timeline

31 Jul 2026	Recall initiated by company
11 Sep 2026	Classified by FDA	+42 days
23 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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