FDA Device recall Z-2000-2025
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, STERI…
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of 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, STERI… by Becton Dickinson Infusion Therapy Systems, citing due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2000-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-21 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson Infusion Therapy Systems |
| Distribution | US |
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
Reason
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Identifiers
| code_info | Lot: 4222721/ UDI: 382903826339 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2000-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.