Class II — Bayer Medical Care, Inc.
| Recalling firm | Bayer Medical Care Inc. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. |
| Product | MEDRAD® Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT; |
| Quantity | 27800 kits (556 boxes) |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-07-31 |
| Classified | 2026-09-11 |
| Recall number | Z-3147-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bayer Medical Care, Inc. (Z-3147-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99698/
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