BD Insyte IV Catheter needle may fail to retract properly
Becton Dickinson is recalling BD Insyte Autoguard IV catheters because the needle may be slow to retract or fail to retract. This poses a potential needlestick injury risk to healthcare workers.
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 FDA Class II medical device recall with no reported injuries or illnesses. However, it involves a safety mechanism (needle retraction) on a device used by healthcare workers, presenting a risk of occupational needlestick injury even though no harm has yet been reported, meeting the rubric criterion for Score 3.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard Shielded IV Catheters (18 GA x 1.16 in / 1.3 x 30 mm, REF 382544) due to customer complaints regarding needle retraction.
The catheters are designed with a safety mechanism that retracts the needle after insertion to protect healthcare workers. Due to customer complaints, there is a possibility that the catheter needle may be slow to retract or fail to retract completely. This poses a potential needlestick injury risk.
The affected product was distributed worldwide, including throughout the United States and internationally to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam. The affected lot is Lot# 4312025 (UDI: 00382903825448).
Healthcare facilities and providers should stop using the affected lot immediately. For questions or concerns, contact the manufacturer using information on the product label or packaging.
The recalled product
- Product
- REF: 382544 BD Insyte Autoguard 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
- Hazard
- needle-retraction-failure
- sharp-injury-risk
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# 4312025 UDI: 00382903825448
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03