MEDRAD Stellant FLEX Syringe Kit recallZ-3147-2026 · Bayer Medical Care, Inc. · initiated Jul 31, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bayer Medical Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-3147-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- Bayer Medical Care, Inc.
- Quantity
- 27800 kits (556 boxes)
- Product code
- DXT
- FDA submissions
- K182273
- Distribution
- US Nationwide distribution.
Product description
MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Code information (models, lots, serial numbers)
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDRAD® Stellant FLEX Syringe Kit FLEXS-150-QFTBayer Medical Care Inc. · Injector And Syringe, Angiographic1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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