MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
FDA Recall Z-3147-2026 · Posted 2026-09-11
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Recalling FirmBayer Medical Care, Inc.
Recall StatusOpen, Classified
Product CodeDXT
Date Initiated2026-07-31
Product Quantity27800 kits (556 boxes)
Reason for Recall
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Firm 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.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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