BD Insyte Autoguard recallZ-2001-2025 · Becton Dickinson Infusion Therapy Systems, Inc. · initiated May 21, 2025

Why it was recalled

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

FDA root cause category: Component design/selection

What the company is doing

On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.

Recall details

Recall number

Z-2001-2025

Status

Open, Classified

Initiated by the company

May 21, 2025

Posted by the FDA

Jun 23, 2025

Recalling firm

Becton Dickinson Infusion Therapy Systems, Inc.

Quantity

50 units

Product code

FOZ

FDA submissions

K201075

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD Insyte Autoguard 381533

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall34 reports

Product lines

• BD Insyte AutoguardBecton, Dickinson And Company · 33 models · 4,465 reports · 8 recalls

Other devices under the same FDA submission

53 devices cleared under K201075 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• BD Insyte Autoguard 382523

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  660 reports
• BD Insyte Autoguard 382533

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls527 reports
• BD Insyte Autoguard Shielded IV Catheter 381823

  Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days
  582 reports
• BD Insyte Autoguard 381423

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall528 reports
• BD Insyte Autoguard 382544

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall437 reports
• BD Insyte Autoguard Shielded IV Catheter 381834

  Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days
  388 reports
• BD Insyte Autoguard 381433

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall314 reports
• BD Insyte Autoguard 382534

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  359 reports
• BD Insyte Autoguard 381434

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall303 reports
• BD Insyte Autoguard Shielded IV Catheter 381812

  Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days
  304 reports
• BD Insyte Autoguard 381412

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  294 reports
• BD Insyte Autoguard 382633

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall126 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 96865).

• Z-1999-2025 · Open, Classified
  REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
• Z-2000-2025 · Open, Classified
  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
• Z-2002-2025 · Open, Classified
  REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
• Z-2003-2025 · Open, Classified
  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
• Z-2004-2025 · Open, Classified
  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
• Z-2005-2025 · Open, Classified
  REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
• Z-2006-2025 · Open, Classified
  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
• Z-2007-2025 · Open, Classified
  REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly