Z-3147-2026Class II

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

Name: Z-3147-2026 MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT
Creator: Bayer Medical Care, Inc.
Published: 2026-07-31
License: https://open.fda.gov/license/

Bayer Medical Care, Inc. / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3147-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-11
Recalling firm: Bayer Medical Care, Inc.
Product: MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
FDA root cause: Employee error
Action: On or about July 31, 2026, consignees were notified via telephone followed by sending URGENT MEDICAL DEVICE RECALL letters. Actions to be taken: 1. Review your inventory for affected product and to quarantine any loose/unboxes product from the lot. 2. Whether or not Box 0855 of Lot 8688750 is found to be in your inventory/possession, we will need you to please confirm that information for our records by filling out and returning the response form provided. 3. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.
Quantity in commerce: 27800 kits (556 boxes)
Distribution: US Nationwide distribution.
Product codes and lots: Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3147-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3147-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code DXT

K182273Class IIMEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTBayer Medical Care, Inc. / cleared 2018-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)