# FDA recall Z-2002-2025

> **Becton Dickinson Infusion Therapy Systems, Inc.** · Class II · device recall initiated 2025-05-21.

## Product

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

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-2002-2025
- **Recalling firm:** Becton Dickinson Infusion Therapy Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sandy, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2002-2025

## Citation

> AI Analytics. FDA recall Z-2002-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2002-2025. Source: US FDA. Licensed CC0.

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