Use caution Medical device recall · FDA · Published October 4, 2023

BD Insyte Autoguard BC Shielded IV Catheter Recall: Risk of Contaminated Needlestick

Becton Dickinson recalls BD Insyte Autoguard BC Shielded IV Catheters with blood control technology due to potential needlestick injuries from improper needle retraction. Affected units have specific model and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0400-2024Medical device Becton Dickinson ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBecton Dickinson Infusion Therapy Systems Inc.9450 S State St · Sandy, UT 84070-3213

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling BD Insyte Autoguard BC Shielded IV Catheters that may cause contaminated needlestick injuries if needles don't retract properly. This could lead to blood leaks or repeated catheter insertions. Read more at govinfonow.com/recall/57164-bd-insyte-autoguard-bc-shielded-iv-catheter-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/57164-bd-insyte-autoguard-bc-shielded-iv-catheter-recall-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0400-2024

Cite this page

“BD Insyte Autoguard BC Shielded IV Catheter Recall: Risk of Contaminated Needlestick.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57164-bd-insyte-autoguard-bc-shielded-iv-catheter-recall-risk-of. Based on FDA recall #Z-0400-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2024%22&limit=1).

The FDA announced on 2023-10-04 that Becton Dickinson Infusion Therapy Systems Inc. is recalling BD Insyte Autoguard BC Shielded IV Catheters due to potential needlestick injuries and blood leakage. The agency issued Class II recall Z-0400-2024 for the affected devices distributed nationwide.

How to tell if you have it

Brand: Becton Dickinson
Product: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology
Size/Length: 20GA X 1.00in
REF: 382533
UDI-DI: 00382903825332
Lot: 3166524
Expiration: 2026/05/31
Units affected: 528,000

The hazard

The intravascular catheters may have needles that do not retract properly into the barrel. This defect could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts if the catheter is inadvertently removed.

Context

GovInfoNow's records show Becton Dickinson Infusion Therapy Systems, Inc. has 6 other recalls on record since 2021-09-08. Other recent recalls of similar products include BD Insyte Autoguard IV Catheter Recall: Slow Needle Retraction Risk (2025-05-21), BD Cathena Safety IV Catheter Recall: Risk of Blood Leakage During Insertion (2025-04-21), and BD Insyte Autoguard BC IV Catheters May Leak During Insertion - Recall (2024-06-26). Additional recent recalls include Becton Dickinson Swan-Ganz Jr Catheter Recall: Leaking Hub Risk (2026-04-08), Becton Dickinson Swan-Ganz Catheter Recall: Risk of infection from leaking hub (2026-04-08), and Stryker Daig Livewire Steerable BDB Catheter Recall: Incomplete Sterile Seals (2026-04-10).

How to tell if you have this one

Check for the model number 20GA X 1.00in, reference number 382533, lot number 3166524, and expiration date 2026/05/31 on the catheter packaging.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Catheter Packaging
Look for the model number 20GA X 1.00in, reference number 382533, lot number 3166524, and expiration date 2026/05/31.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 4, 2023Firm started the recall
Nov 24, 2023FDA classified it Class II
Dec 6, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Becton Dickinson recalls

Link to this recall

<a href="https://govinfonow.com/recall/57164-bd-insyte-autoguard-bc-shielded-iv-catheter-recall-risk-of">BD Insyte Autoguard BC Shielded IV Catheter Recall: Risk of Contaminated Needlestick (GovInfoNow)</a>

Where this comes from

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-0400-2024 (October 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0400-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.