BD Insyte Autoguard Shielded IV Catheter needle retraction defect
Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly or fail to retract completely.
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: This is an FDA Class II recall involving a risk-of-harm medical device (needle retraction failure in an IV catheter presents a potential for needlestick injury). The source text does not report any illnesses or injuries, but the hazard is inherent to the product defect, not merely theoretical.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling Lot #4290664 of the BD Insyte Autoguard Shielded IV Catheter (REF 381433, 20GA x 1.00 in, 1.1x25 mm, 65 mL/min, STERILE, Rx Only). According to customer complaints, the catheter needle may be slow to retract or fail to retract.
The recalled product was distributed worldwide, including across the United States and to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam. A total of 50 units were affected.
If you have this product in use or in stock, contact Becton Dickinson Infusion Therapy Systems, Inc. for instructions on how to proceed. Healthcare providers should review their inventory for the affected lot number (4290664/UDI: 382903814336) and follow the manufacturer's guidance.
The recalled product
- Product
- REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 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 # 4290664/UDI:382903814336
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 BC Pro IV Catheter Needle Retraction Defect
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard Shielded IV Catheter needle retraction failure
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 Winged Shielded IV Catheter Needle Retraction Issue
FDA (Devices) · 2025-07-02
- HighBD Insyte Autoguard Shielded IV Catheter needle retraction malfunction
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