FDA recall, , Moderate risk
EndoVive Safety PEG Kit
The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Marlborough, Massachusetts, recalled the EndoVive Safety PEG Kit because the kits utilized ChloraPrep Triple Swabsticks from BD with open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution.
The component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. The recall began on February 10, 2026, and was added to the FDA's Enforcement Report on March 11, 2026.
The recalled kits were distributed nationwide in the United States. The recall involved 806 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
- UDI-DI
- 08714729880394
- 08714729880387
- 37435463
- 37522541
- 37528545
- 37546847
- 37546850
- 37546849
- 37550500
- 37592036
- 37732292
- 37435462
- 37514809
- 37525231
- 37536563
- 37536564
- 37536562
- 37546840
- 37583642
- 37731897
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98412
- Recall number
- Z-1551-2026
- Quantity recalled
- 806 units
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
