The Recall Desk
HighFDA (Devices)·Z-1808-2025·Announced 2025-05-28

BD Cathena Safety IV Catheter manufacturing defect hole septum

Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.

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 an FDA Class II recall of a medical device with a manufacturing defect that poses a risk of harm (blood exposure, therapy delay) without reported illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported meets the High (3) threshold.

Plain-English summary

Becton Dickinson Infusion Therapy Systems, Inc. is recalling certain BD Cathena Safety IV Catheter models nationwide and internationally due to a manufacturing defect. The affected products are: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN (REF: 386865); BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC (REF: 386803); and BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN (REF: 386862).

The recalled catheters may have a hole in the septum, which may result in blood leakage from the septum during insertion. This defect may cause blood exposure to healthcare workers or the need for a second IV to be placed, potentially resulting in therapy delay.

Approximately 262,800 units have been distributed. Healthcare facilities and providers using these catheters should stop using them and contact Becton Dickinson for replacement or credit. Patients with questions should consult their healthcare provider.

The recalled product

Product
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Category
Medical Device — IV Catheter
Hazard
  • manufacturing-defect
  • blood-leakage
  • blood-exposure
  • therapy-delay

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 (3)

  • REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027
  • 386803/0100382903868032/4247809/31-Aug-2027
  • 386862/0100382903868629/4237744/31-Aug-2027

Distribution

Distributed nationwide across the United States.

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