Class II — Bolton Medical Inc.
| Recalling firm | BOLTON MEDICAL, INC. |
|---|---|
| Registered facility | BOLTON MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The product may be shorter than packaging indicates |
| Product | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX |
| Quantity | 129 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. |
| Initiated | 2022-12-20 |
| Classified | 2023-01-19 |
| Recall number | Z-0997-2023 |
| 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 — Bolton Medical Inc. (Z-0997-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91292/
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