BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Brand
Becton Dickinson Infusion Therapy Systems, Inc.
Lot Codes / Batch Numbers
Lot: 4222721/ UDI: 382903826339
Products Sold
Lot: 4222721/ UDI: 382903826339
Becton Dickinson Infusion Therapy Systems, Inc. is recalling REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA due to Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Recommended Action
Per FDA guidance
On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026