Bolton Medical Inc.
FDA Regulatory Profile
Bolton Medical Inc. appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2160-2026, Class I) was initiated on April 22, 2026. Its most recent 510(k) clearance was granted on August 23, 2002.
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2160-2026 | Class I | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1 | April 22, 2026 |
| Z-1383-2024 | Class II | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and pati | February 22, 2024 |
| Z-1689-2023 | Class II | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main | May 3, 2023 |
| Z-0998-2023 | Class II | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX | December 20, 2022 |
| Z-0997-2023 | Class II | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | December 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K021996 | BOLTON PTA CATHETER | August 23, 2002 |