CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled
Becton Dickinson Infusion Therapy Systems is recalling REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, distributed nationwide in the US. The recall was initiated on 21 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2003-2025
- FDA event ID
- 96865
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Sandy, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2025
- FDA classified
- 23 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 21 May 2025 | Recall initiated by company | |
| 23 Jun 2025 | Classified by FDA | +33 days |
| 2 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Is REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled?
Yes. Becton Dickinson Infusion Therapy Systems recalled REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter on 21 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-2003-2025.
Why was it recalled?
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Which lots are affected?
Lot# 4298108/UDI:382903829446
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Becton Dickinson Infusion Therapy Systems
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: 382633, BD Insyte Autoguard BC Winged recalled | Becton Dickinson Infusion Therapy Systems | Sterility | Nationwide |
| Device | CLASS II | REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled | Becton Dickinson Infusion Therapy Systems | Sterility | Nationwide |
| Device | CLASS II | REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA recalled | Becton Dickinson Infusion Therapy Systems | Sterility | Nationwide |
| Device | CLASS II | REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X recalled | Becton Dickinson Infusion Therapy Systems | Sterility | Nationwide |
| Device | CLASS II | REF: 381433, BD Insyte Autoguard Shielded IV Catheter recalled | Becton Dickinson Infusion Therapy Systems | Sterility | Nationwide |
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