BD Insyte Autoguard Shielded IV Catheter needle retraction malfunction
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard Shielded IV Catheters due to reports that the catheter needle may be slow to retract or fail to retract.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The FDA classified this as a Class II recall involving a medical device with a mechanical malfunction (needle retraction failure) that poses a risk of patient injury. Although no illnesses or injuries are reported in the source text, the hazard is real and not merely theoretical, placing this at the High level per the rubric.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling REF 382544 BD Insyte Autoguard Shielded IV Catheters (18 GA x 1.16 in, 95 mL/min) distributed worldwide including across the United States, Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
The recall was initiated due to customer complaints regarding a potential defect in which the catheter needle may be slow to retract or fail to retract completely. This defect affects Lot# 4312025 with UDI 00382903825448, comprising 50 units.
Patients and healthcare providers who have received or used this product should contact Becton Dickinson Infusion Therapy Systems, Inc. for further instructions regarding the affected catheters.
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
- Affected units
- 50
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
Part of a larger recall action
This product is one of 9 recalled by Becton Dickinson Infusion Therapy Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Becton Dickinson Infusion Therapy Systems, Inc.
See all →- HighBD Insyte Autoguard Shielded IV Catheter needle retraction failure recall
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard BC Pro Winged Shielded IV Catheter Needle Retraction Issue
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard BC Winged IV Catheter Needle Retraction Issue
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard Shielded IV Catheter needle retraction defect
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard BC Pro IV Catheter Needle Retraction Defect
FDA (Devices) · 2025-07-02
Same hazard · needle retraction failure
See all →- HighMedline IV Catheters Recalled for Needle Retraction Failure
FDA (Devices) · 2025-07-09
- HighMedline retinal packs recalled because catheter needle may fail to retract
FDA (Devices) · 2025-07-09
- HighBD Insyte Autoguard Shielded IV Catheter needle retraction failure
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard Winged Shielded IV Catheter Needle Retraction Issue
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard Winged IV Catheter needle retraction failure recall
FDA (Devices) · 2025-07-02
Similar recalls
- HighBD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly
FDA (Devices) · 2023-12-06
- HighBD Insyte Autoguard Catheter Recall for Potential Body Damage
FDA (Devices) · 2014-12-17
- HighBD Insyte Autoguard BC IV Catheter Recalled for Tubing Defect and Leakage
FDA (Devices) · 2024-08-07
- HighBD Cathena IV Catheter Safety Shield May Fail to Properly Engage
FDA (Devices) · 2023-10-11
- HighMedline IV Catheters Recalled for Needle Retraction Failure
FDA (Devices) · 2025-07-09
- HighBD Cathena Safety IV Catheter manufacturing defect hole septum
FDA (Devices) · 2025-05-28