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.
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.
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.
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.
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.
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.
Look for model numbers RLV0035, RLV0045, RLV0055, RLV0065, or RLV0075 on the instrument packaging or label.
Confirm the lot numbers and expiration dates listed in the recall notice to determine if your instruments are affected.
The outer tray seal may have been breached, potentially introducing contaminants and leading to severe infections during medical procedures.
Check for model numbers RLV0035, RLV0045, RLV0055, RLV0065, or RLV0075 and verify the lot numbers and expiration dates against the provided ranges.
No, but you should check if your instruments are affected and follow the recall instructions to ensure safety.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2694-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2694-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
