FDA Medical devices recall ·
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection… recall
- Recall number
- Z-3147-2026
- Date
- (initiated July 31, 2026)
- Company / brand
- Bayer Medical Care, Inc.
1 Bayer Dr, Indianola, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27800 kits (556 boxes)
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Why was it recalled?
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3147-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.