REF: 381433 — Class II medical device recall Z-2002-2025
Ongoing recall by Becton Dickinson Infusion Therapy Systems, Inc., reported 2025-07-02, distributed nationwide. Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to re
| Recall number | Z-2002-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, United States |
| Recall initiated | 2025-05-21 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CL, CO, GT, JP, NZ, PA, PH, SG, VN |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 00382903814336 |
| Lot numbers | 4290664 |
| Model numbers | 381433 |
Product
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Reason for recall
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2002-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.