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
#BarcodesProduct as published
1M00509001
2Inner Box Material Number (UPN): M00509000
308714729880394Outer Box UDI: 08714729880394
408714729880387Inner Box UDI: 08714729880387
5Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292
6Inner 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:44 PM UTC

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