High FDA (Devices)·Z-0349-2024·Announced 2023-11-29

BD Alaris Pump Infusion Sets Contain Undisclosed DEHP

BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.

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: This is a Class II recall involving a known hazardous substance (DEHP) in products labeled as free from it. While no illnesses or injuries have been reported, DEHP poses documented reproductive and developmental health risks, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling multiple BD Alaris Pump infusion sets due to a labeling discrepancy. The affected sets are labeled as free of di(2-ethylhexyl) phthalate (DEHP), but they actually contain DEHP.

DEHP is a phthalate chemical that poses health concerns, particularly regarding reproductive and developmental effects. Medical professionals and patients relying on the DEHP-free labeling may unknowingly expose patients to this substance during infusion therapy.

The recall affects numerous catalog numbers of BD Alaris infusion sets distributed worldwide, including throughout the United States in all 50 states, Washington DC, Puerto Rico, and Guam, as well as internationally to Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates. All lots with expiration dates through July 31, 2026 are included.

Healthcare facilities should immediately discontinue use of the affected infusion sets and contact BD customer service for guidance on replacement products. Consult with your healthcare provider regarding any potential exposure.

The recalled product

Product: BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD Alar
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion Sets
Hazard: dehp
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 (20)

UDI-DI: 10885403232602
Catalog # 10010483
UDI-DI: 07613203021135
Catalog # 10010453
UDI-DI: 07613203015806
Catalog # 10010454
UDI-DI: 07613203021210
Catalog # 10013072
UDI-DI: 10885403221965
Catalog # 10013361
UDI-DI: 10885403232268
Catalog # 10013890
UDI-DI: 10885403233951
Catalog # 10015012
UDI-DI: 10885403221866
Catalog # 10015862
UDI-DI: 07613203019668
Catalog # 10062818
UDI-DI: 07613203019187
Catalog # 10821753

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Becton Dickinson & Company

See all →

Severe
BD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
Severe
BD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
Severe
BD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10

Same hazard · dehp