CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report

REF: 382633, BD Insyte Autoguard BC Winged recalled

Becton Dickinson Infusion Therapy Systems is recalling REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with, 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

Lot, batch or date codesLot: 4222721/ UDI: 382903826339

Quantity recalled50

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-2000-2025
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: Device Malfunction
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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

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 Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

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: 4222721/ UDI: 382903826339

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 96865

This product is part of a recall event; the main page for the event is REF: 381434 BD Insyte Autoguard Shielded IV Catheter recalled.

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025	CLASS II	REF: 381434 BD Insyte Autoguard Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 382544 BD Insyte Autoguard Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 381433, BD Insyte Autoguard Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025	CLASS II	REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide

More recalls from Becton Dickinson Infusion Therapy Systems

All 15

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381433, BD Insyte Autoguard Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide