Becton Dickinson Infusion Therapy Systems Inc.: Medical Device Recall in 2023 - (Recall #: Z-0400-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: December 6, 2023

Recall Number: Z-0400-2024

Event ID: 93276

Reason for Recall:

Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

Status: Ongoing

Product Quantity: 528,000

Code Information:

UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31

Distribution Pattern:

US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.

Voluntary or Mandated:

Voluntary: Firm initiated