Boston Scientific Intracept Access Instruments Recall: Risk of Sterility Breach
Boston Scientific recalls Intracept Access Instruments (RLV0035, RLV0045, RLV0055, RLV0065, RLV0075) due to potential sterile barrier breach in the outer tray seal, which could lead to severe infection. Affected units have specific lot numbers and expiration dates.
Lower-risk 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.
Contact the company
What happened, in plain English
Boston Scientific is recalling Intracept Access Instruments that may have a sterile barrier breach in the outer tray seal. This could introduce infection risks during medical procedures. Affected units include specific model numbers and lot ranges with expiration dates. Read more at govinfonow.com/recall/49403-boston-scientific-intracept-access-instruments-recall-risk-of-sterility-breach.
Source Summary by GovInfoNow · govinfonow.com/recall/49403-boston-scientific-intracept-access-instruments-recall-risk-of-sterility-breach · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2694-2026
Cite this page
“Boston Scientific Intracept Access Instruments Recall: Risk of Sterility Breach.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49403-boston-scientific-intracept-access-instruments-recall-risk-of-sterility-breach. Based on FDA recall #Z-2694-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2694-2026%22&limit=1).
Why it’s dangerous
The outer tray seal of the instruments may have been breached, potentially introducing contaminants. If the seal is compromised, the instruments could lead to severe infections during medical procedures.
Who’s affected
Medical professionals using these instruments for procedures like nerve ablation. Patients who have received these instruments during surgery are at risk of infection if the seal was compromised.
How to tell if you have this one
Check for model numbers RLV0035, RLV0045, RLV0055, RLV0065, or RLV0075. Affected units have specific lot numbers and expiration dates ranging from March 2026 to March 2028.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Product Details
Look for model numbers RLV0035, RLV0045, RLV0055, RLV0065, or RLV0075 on the instrument packaging or label.
Verify Lot Numbers
Confirm the lot numbers and expiration dates listed in the recall notice to determine if your instruments are affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these instruments immediately?
No, but you should check if your instruments are affected and follow the recall instructions to ensure safety.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2694-2026 (April 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2694-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.