Quick Facts at a Glance
- Recall Date
- February 10, 2026
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Product type
- PEG Kit
- Model numbers
- Outer Box Material Number (UPN): M00509001, Inner Box Material Number (UPN): M00509000, Outer Box UDI: 08714729880394, Inner Box UDI: 08714729880387, Outer Box Lot#: 37435463, 37522541, 37528545, 37546847 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 10, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The EndoVive Safety PEG Kit is used for percutaneous endoscopic gastrostomy procedures. Kits include components to assist after gastrostomy tube placement.
Why This Is Dangerous
The issue revolves around compromised seals on BD ChloraPrep Triple Swabsticks, which could allow loss of sterility or drying of antiseptic solution, potentially impacting patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Facilities may experience workflow interruptions and needs to verify the sterility of prepared kits before patient use. The recall could affect procurement and sterilization protocols in hospitals.
Practical Guidance
How to identify if yours is affected
- Verify UPN and lot numbers on Outer/Inner boxes (M00509001 and M00509000) and UDIs (08714729880394, 08714729880387).
- Check against recall list provided by Boston Scientific and the FDA page.
- Review inventory for affected BD ChloraPrep Triple Swabsticks components.
Where to find product info
Recall notice and detailed instructions are posted on FDA enforcement page linked above.
What timeline to expect
Refunds or replacements follow the hospital's recall process; typical timelines range from several weeks to a couple of months depending on stock and承
If the manufacturer is unresponsive
- Escalate to hospital procurement or infection control leadership.
- File a formal recall inquiry with Boston Scientific via the recall portal or customer service.
- Contact FDA consumer safety hotlines if unresolved.
How to prevent similar issues
- Vet suppliers’ sterility controls and packaging integrity before purchase.
- Request verified sterile packaging and lot-level traceability.
- Monitor recall alerts from FDA and manufacturer on a routine basis.
Documentation advice
Keep the recall letter, shelf labels, lot numbers, UDIs, and correspondences with the manufacturer. Photograph affected packaging for records.
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Product Details
Quantity: 806 units Brand: Boston Scientific Product: EndoVive Safety PEG Kit UPNs: Outer Box M00509001; Inner Box M00509000 UDIs: Outer Box 08714729880394; Inner Box 08714729880387 Outer Box Lot#: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292 Inner Box Lot#: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840 Sold in: United States nationwide Recall date: 2026-02-10 Status: ACTIVE Remedy: Follow manufacturer recall instructions; contact Boston Scientific or healthcare provider for instructions.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- BD ChloraPrep swabstick issue
- M00509001 outer box, M00509000 inner box
- Recall status ACTIVE
- Sterility risk from compromised seals
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Safety Guide
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