Bayer Medical Care recall: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
Bayer Medical Care, Inc. is recalling MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System – 27800 kits (556 boxes). The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 31, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System |
| Brand | Bayer Medical Care |
| Company | Bayer Medical Care, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 31, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 27800 kits (556 boxes) |
| Recall ID | 99698 |
Recalled products
- MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- FDA recall number
- Z-3147-2026
- Codes, lots and dates
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Quantity
- 27800 kits (556 boxes)
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99698
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Indianola, PA, United States
Why it was recalled
The reason the FDA lists: “Some devices may not have been properly sterilized due to a manufacturing sterilization issue.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99698, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Bayer Medical Care MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recalled?
Yes. Bayer Medical Care, Inc. recalled it on July 31, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.