The Recall Desk
HighFDA (Devices)·Z-1970-2025·Announced 2025-06-18

BD Alaris Infusion Sets May Leak, Risking Hazardous Drug Exposure

BD infusion sets may leak at the luer connector, potentially exposing patients to hazardous drugs or causing medication underdosing. Multiple product types are affected.

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 medical device recall for a risk-of-harm product where potential serious consequences (hazardous drug exposure, medication underdosing) exist but no injuries or illnesses have been reported. Per the severity rubric, this is a high-risk situation without reported harm.

Plain-English summary

BD has recalled Alaris Pump Infusion Sets and related closed system drug transfer devices. These are sterile, single-use medical devices used in healthcare settings to deliver medications to patients.

The recalled devices may leak where the closed male luer component connects to the needle-free connector. Leakage can occur during patient treatment and may cause delays in medication delivery, interruption of treatment, exposure to hazardous drugs, or underdosing of medication.

The recall affects more than 2 million units that have been distributed worldwide, including throughout the United States. Healthcare providers and patients using these devices should verify the device model and lot numbers.

The recalled product

Product
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Infusion Set / Drug Delivery
Hazard
  • leakage
  • hazardous-drug-exposure
  • underdosing
  • treatment-interruption

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)

  • REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10
  • 2026)
  • 23035235(March 11
  • 23045223(April 6
  • 23075395(July 17
  • 23085227(August 8
  • 23115150(November 8
  • 23115151(November 8
  • 23125167(December 5
  • 24025684(February 6
  • 2027)
  • 24045377(April 23
  • 24055576(May 27
  • 24075224(July 26
  • 24105079(October 11
  • 24115159(November 7
  • 10321213T/10885403228971/23035169(March 15
  • 23045174(April 4
  • 23085140(August 3
  • 23095142(September 11

Distribution

Distributed nationwide across the United States.

Related recalls

Same category