The Recall Desk
HighFDA (Devices)·Z-1999-2025·Announced 2025-07-02

BD Insyte Autoguard IV Catheter Needle Retraction Failure Recall

Becton Dickinson is recalling BD Insyte Autoguard IV catheters where the needle may be slow or fail to retract due to customer complaints. Affected lot: 4229661.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II device recall involving failure of a safety-critical mechanism (needle retraction) on a shielded IV catheter. Although no illnesses or injuries are reported in the source, the potential for needle stick injuries and related harm makes this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard Shielded IV Catheters (model 381423, 22GA X 1.00 IN) due to a potential defect in the needle retraction mechanism.

The company has received customer complaints indicating that the catheter needle may be slow to retract or fail to retract completely after insertion.

The affected product is lot #4229661 (UDI: 382903814237) with 50 units. The product was distributed worldwide, including throughout the United States and to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.

The recalled product

Product
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Category
Medical Device — IV Catheter
Hazard
  • needle-retraction-failure
  • needle-stick-hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 4229661/UDI: 382903814237

Distribution

Distributed nationwide across the United States.

Related recalls

Same category