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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Stellant FLEX Syringe Kit

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 Class 2 Device Recall MEDRAD Stellant FLEX Syringe Kitsee related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3147-2026
Recall Event ID 99698
510(K)NumberK182273 
Product Classification Injector and syringe, angiographic - Product Code DXT
ProductMEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Code Information Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
FEI Number 2520313
Recalling Firm/
Manufacturer		 Bayer Medical Care, Inc.
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information ContactLindsay Metkler
412-406-2153
Manufacturer Reason
for Recall		Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
FDA Determined
Cause 2		Employee error
ActionOn 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 Commerce27800 kits (556 boxes)
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXT
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