Intracept Access Instruments — Class II medical device recall Z-2694-2026
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2026-07-15, distributed nationwide. Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which m
| Recall number | Z-2694-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2026-04-22 |
| Classified | 2026-07-08 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, GB |
| Quantity | 37,764 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00852454006226, 00852454006240, 00852454006257, 00852454006301, 00852454006318, 00852454006424, 00852454006431, 00852454006448, 00852454006455 |
Product
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU
Reason for recall
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2694-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.