BD Insyte Autoguard BC Shielded IV Catheter with Blood Control… — Class II medical device recall Z-0400-2024
Ongoing recall by Becton Dickinson Infusion Therapy Systems Inc., reported 2023-12-06, distributed nationwide. Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which
| Recall number | Z-0400-2024 |
|---|---|
| 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 | 2023-10-04 |
| Classified | 2023-11-24 |
| Reported by FDA | 2023-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 528,000 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00382903825332 |
| Lot numbers | 2026/05/31, 3166524 |
| Model numbers | 382533 |
Product
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Reason for recall
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
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-0400-2024. 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.