BD Cathena IV Catheters recalled due to septum defect causing blood leakage
Becton Dickinson is recalling BD Cathena Safety IV Catheters 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 medical device recall with no reported injuries or hospitalizations. The defect presents a theoretical risk of harm including potential blood exposure during insertion, but without documented patient injury. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
BD Cathena Safety IV Catheters (model variants 386865, 386803, and 386862) are being recalled. The recall affects approximately 262,800 units distributed nationwide across the United States and Canada.
The catheters contain a manufacturing defect that may create a hole in the septum. This defect may result in blood leakage from the septum during insertion, potentially exposing patients to blood or necessitating placement of a second IV catheter, which may delay necessary therapy.
Patients and healthcare providers should contact Becton Dickinson Infusion Therapy Systems, Inc. with questions about affected units. Healthcare facilities should review their inventory and consult with the manufacturer regarding products identified by lot numbers 4198480, 4247809, and 4237744.
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
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.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03