Lower riskMedical device recall · FDA · Published May 21, 2025
BD Insyte Autoguard IV Catheter Recall: Needle May Fail to Retract
Becton Dickinson recalls BD Insyte Autoguard shielded IV catheters due to possible needle failure to retract, which could cause slow or incomplete needle retraction during use.
“BD Insyte Autoguard IV Catheter Recall: Needle May Fail to Retract.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52240-bd-insyte-autoguard-iv-catheter-recall-needle-may-fail-to. Based on FDA recall #Z-2007-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2007-2025%22&limit=1).
Becton Dickinson Infusion Therapy Systems, Inc. recalled BD Insyte Autoguard Shielded IV Catheters due to a potential needle retraction failure, according to the FDA on May 21, 2025.
How to tell if you have it
Brand: Becton Dickinson
Product: BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
REF: 381434
Lot#: 4116814
UDI: 00382903814343
The hazard
The recall addresses customer complaints indicating that the catheter needle may be slow to retract or fail to retract entirely. The FDA classified this Class II recall as voluntary and firm-initiated.
Context
GovInfoNow's records show Becton Dickinson Infusion Therapy Systems, Inc. has 6 other recalls on record since September 8, 2021. Other recent recalls of similar products include BD Cathena Safety IV Catheter Recall (April 21, 2025), BD Insyte Autoguard BC IV Catheters May Leak During Insertion (June 26, 2024), and BD Insyte Autoguard BC Shielded IV Catheter Recall (October 4, 2023). Other recent recalls of similar products include Stryker Daig Livewire Steerable BDB Catheter Recall (April 10, 2026), Stryker Daig Livewire Steerable Catheter Recall (April 10, 2026), and Medline Medical Procedure Kits: Catheter Issues Recalled (May 4, 2026).
How to tell if you have this one
Look for the BD Insyte Autoguard shielded IV catheter with 20-gauge, 1.16-inch length, 60 mL/min flow rate, and sterile packaging. The lot number 4116814 or UDI 0038290381433 is associated with this recall.
Brand
Becton Dickinson
Category
Medical device
FDA recall event · 9 products
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-1999-2025
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY; Lot # 4229661/UDI: 382903814237
50
Z-2000-2025
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; Lot: 4222721/ UDI: 382903826339
50
Z-2001-2025
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly; Lot # 4282452/UDI: 382903815333
50 units
Z-2002-2025
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly; Lot # 4290664/UDI:382903814336
50 units
Z-2003-2025
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; Lot# 4298108/UDI:382903829446
50 units
Z-2004-2025
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; Lot# 4208538/UDI: 00382903818112
50 units
Z-2005-2025
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly; Lot# 4312025 UDI: 00382903825448
50 units
Z-2006-2025
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; Lot# 4282308/UDI: 382903819232
50 units
Z-2007-2025
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly; Lot# 4116814/ UDI: 00382903814343
50 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product's lot number (4116814) or unique device identifier (UDI: 0038290381433) to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 40 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2007-2025 (May 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2007-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.