BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP
BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.
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 with no reported illnesses or injuries. The hazard—DEHP exposure in medical devices—presents potential health risks but no actual harm has been documented. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD gravity blood infusion sets (Catalog #4030B-07T and #42081E) because they are labeled as free of DEHP (di(2-ethylhexyl) phthalate) but actually contain the substance. DEHP is a plasticizer that FDA regulates in medical devices due to potential health risks.
The affected infusion sets were distributed worldwide, including all 50 U.S. states, Puerto Rico, Guam, and multiple international countries. The recall covers all lots with expiration dates through July 31, 2026.
No illnesses or injuries have been reported related to this issue. Patients and healthcare providers who have received these infusion sets should contact Becton Dickinson & Company or their healthcare provider for guidance.
The recalled product
- Product
- BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- dehp-exposure
- 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 (6)
- UDI-DI: 10885403240867
- Catalog # 4030B-07T
- UDI-DI: 07613203020855
- Catalog # 42081E. All lots
- thru expiration date July 31
- 2026.
Distribution
Distributed nationwide across the United States.
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