BD Extension Sets Mislabeled as DEHP-Free Despite Containing Phthalates
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving mislabeling of DEHP content, a restricted substance in medical devices. No illnesses or injuries have been reported, but this is a risk-of-harm product where the hazard is confirmed but injury has not yet been reported, meeting the rubric threshold for High severity.
Plain-English summary
BD Extension Sets with multiple catalog numbers are the subject of this recall due to a labeling discrepancy. These products are labeled as free of DEHP (di(2-ethylhexyl) phthalate), but testing has determined they actually contain DEHP, a phthalate plasticizer.
DEHP is a substance that FDA restricts in certain medical device applications due to health concerns. The mislabeling means patients and healthcare providers received medical devices labeled as DEHP-free when they actually contained this restricted substance.
The affected extension sets have been distributed worldwide, including throughout the United States and to countries including Australia, Brazil, Canada, India, Mexico, the Philippines, and others. All lots manufactured through October 16, 2026 are affected.
Healthcare providers and patients who have these extension sets should contact Becton Dickinson & Company or the FDA for further guidance on this recall.
The recalled product
- Product
- BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog
- Manufacturer
- Becton Dickinson & Company
- Hazard
- dehp-contamination
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI-DI: 10885403233814
- Catalog # 10013902 UDI-DI: 07613203011853
- Catalog # 20062E
- UDI-DI: 10885403226120
- Catalog # 70000N-07
- UDI-DI: 10885403236112
- Catalog # ME1224
- UDI-DI: 10885403229756
- Catalog # 20350ET
- UDI-DI: 10885403240997
- Catalog # 70001B-07T. All lots
- thru expiration date October 16
- 2026.
Distribution
Distributed nationwide across the United States.
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