Becton Dickinson Infusion Therapy Systems Inc.

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ10,489
• Set, Administration, IntravascularFPA582
• Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA333
• Syringe, PistonFMF33
• Introducer, CatheterDYB30
• Needle, Hypodermic, Single LumenFMI25
• Brush, Scrub, Operating-RoomGEC16
• Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemONB7
• Flow Cytometric Reagents And Accessories.OYE5
• Coronavirus Antigen Detection Test System.QKP5

Recent recalls

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-06-23Open, ClassifiedComponent design/selection

  REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly

  Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

• 2025-05-21Open, ClassifiedProcess control

  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

  Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.