Intracept Access Instruments
Boston Scientific is recalling Intracept Access Instruments due to a potential sterile barrier breach that could lead to severe infection.
Healthcare facilities should immediately inspect the outer tray seals of all affected instruments. Do not use any product with a compromised seal and contact Boston Scientific for return instructions.
Why it was recalled
Boston Scientific is recalling various Intracept Access Instruments due to a potential sterile barrier breach of the outer tray seal. This compromise may lead to a loss of sterility, posing a risk of severe infection to patients.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Intracept Access Instruments, Description/REF
- Lot code
- RLV0035, 36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751, 04-Mar-2027, 21-Jul-2027
- UDI-DI
- 852454006240, 36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751, 852454006448, 36267790, 36909569
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from Boston Scientific Neuromodulation Corporation
All recalls from Boston Scientific Neuromodulation Corporation
Editorial summary by Recall Canary · summary updated 2026-07-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification