# FDA recall Z-2694-2026

> **Boston Scientific Neuromodulation Corporation** · Class II · device recall initiated 2026-04-22.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.

## Key facts

- **Recall number:** Z-2694-2026
- **Recalling firm:** Boston Scientific Neuromodulation Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-22
- **Report date:** 2026-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2694-2026

## Citation

> MORVS. FDA recall Z-2694-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2694-2026. Source: US FDA. Licensed CC0.

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