Boston Scientific Intracept Access Instruments Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Neuromodulation Corporation is recalling 37,764 units of Intracept Access Instruments due to potential sterile barrier breach that may lead to severe infection.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Boston Scientific Neuromodulation Corporation initiated a voluntary recall of Intracept Access Instruments after determining that the devices may have a sterile barrier breach of the outer tray seal, introducing a risk of sterility breach that could lead to severe infection.
Which Products Are Affected
The recall affects Intracept Access Instruments with the following descriptions and REF numbers: 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. A total of 37,764 units are affected. Specific lot numbers, UDI-DIs, and expiration date ranges are detailed in FDA recall Z-2694-2026. Distribution is nationwide across the United States and worldwide including Great Britain, Germany, and the United Arab Emirates.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm regarding the affected devices.
Why This Matters
The potential sterility breach in these intraosseous nerve ablation system instruments poses a risk of severe infection to patients.
Source
FDA recall Z-2694-2026, Boston Scientific Neuromodulation Corporation, Valencia, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,498 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.