The Recall Desk
HighFDA (Devices)·Z-2003-2025·Announced 2025-07-02

BD Insyte Autoguard BC Pro IV Catheter Needle Retraction Defect

Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (REF 382944) due to reports that the catheter needle may retract slowly or fail to retract completely.

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 an FDA Class II recall of a medical device with a safety mechanism failure (needle retraction). The hazard involves loss of intended safety function in a parenteral delivery device, which is a risk-of-harm scenario. Although no reported illnesses or injuries are stated in the source, the potential for needlestick or other safety compromise warrants a High severity rating.

Plain-English summary

Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm), Reference 382944. The recall was initiated due to customer complaints indicating that the catheter needle may be slow to retract or fail to retract.

The affected product is supplied in units of 50 and has been distributed worldwide and throughout the United States, including to numerous U.S. states and international locations such as Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, the Philippines, Singapore, and Vietnam. The affected lot is Lot# 4298108 with UDI 382903829446.

A failure of the needle to retract properly may interfere with the intended safety function of the device and pose a risk to patients. Healthcare providers and facilities that have received this product should discontinue use of the affected lot immediately and contact Becton Dickinson for instructions on return or replacement. Patients who have received this catheter should consult their healthcare provider if they have concerns.

The recalled product

Product
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
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Category
Medical Device — IV Catheter / Infusion Therapy
Hazard
  • needle-retraction-failure
  • safety-mechanism-defect

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# 4298108/UDI:382903829446

Distribution

Distributed nationwide across the United States.

Related recalls

Same category