Reported Mar 18, 2026 · Ongoing
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- EndoVive Safety PEG Kit
- Outer Box Material Number (UPN)M00509001
- Inner Box Material Number (UPN)M00509000
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 M00509001 2 Inner Box Material Number (UPN): M00509000 3 08714729880394Outer Box UDI: 08714729880394 4 08714729880387Inner Box UDI: 08714729880387 5 Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292 6 Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897 - Amount recalled
- 806 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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