EndoVive Safety PEG Kit recallZ-1551-2026 · Boston Scientific Corporation · initiated Feb 10, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
On February 10, 2026 Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: " Do NOT use affected product (Attachment 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. " Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions. " Return affected product. This removal affects only the products and lots affected. No other material numbers or lots are impacted by this removal. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.
Recall details
- Recall number
- Z-1551-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 10, 2026
- Posted by the FDA
- Mar 11, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 806 units
- Product code
- PIF
- FDA submissions
- K150679
- Distribution
- US Nationwide distribution.
Product description
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Code information (models, lots, serial numbers)
Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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