Recall of Boston Scientific EndoVive Safety PEG Kits with specific box numbers due to potential loss of sterility from compromised swabstick packaging.
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Boston Scientific is recalling EndoVive Safety PEG Kits that include ChloraPrep Triple Swabsticks with packaging that may have open or compromised seals. This could lead to loss of sterility or drying of the antiseptic solution, posing a risk during medical procedures.
The swabsticks are placed outside the sterile barrier of the kit. If the packaging seals are open or compromised, the antiseptic solution could dry out or lose sterility, increasing infection risk during medical procedures.
Patients using the EndoVive Safety PEG Kit for medical procedures are affected. Those with the specific box material numbers listed in the recall are at risk.
Check for the Outer Box Material Number (UPN) M00509001 or Inner Box Material Number (UPN) M00509000 on the packaging. The recall includes specific lot numbers for both outer and inner boxes.
Inspect the swabstick packaging for open or compromised seals, which could indicate loss of sterility.
The recall is due to potential loss of sterility or drying of the antiseptic solution from open or compromised seals on the swabstick packaging.
Check for the Outer Box Material Number (UPN) M00509001 or Inner Box Material Number (UPN) M00509000 on the packaging, as these specific box numbers are part of the recall.
Inspect the swabstick packaging for open or compromised seals. If found, contact Boston Scientific for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1551-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1551-2026 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.
