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

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X recalled

Becton Dickinson Infusion Therapy Systems is recalling REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00, 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 # 4229661/UDI: 382903814237

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-1999-2025
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: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/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

Is REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 recalled?

Yes. Becton Dickinson Infusion Therapy Systems recalled REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 on 21 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1999-2025.

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 # 4229661/UDI: 382903814237

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 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
2 Jul 2025Device	CLASS II	REF: 382633, BD Insyte Autoguard BC Winged recalled	Becton Dickinson Infusion Therapy Systems	Sterility	Nationwide
2 Jul 2025Device	CLASS II	REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Sterility	Nationwide
2 Jul 2025Device	CLASS II	REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA recalled	Becton Dickinson Infusion Therapy Systems	Sterility	Nationwide
2 Jul 2025Device	CLASS II	REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Sterility	Nationwide
2 Jul 2025Device	CLASS II	REF: 381433, BD Insyte Autoguard Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide