Data Foundry

Medical device recalls 2025

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1 — Class II medical device recall Z-1808-2025

Ongoing recall by Becton Dickinson Infusion Therapy Systems, Inc., reported 2025-05-28, distributed nationwide. Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage fro

Recall numberZ-1808-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, United States
Recall initiated2025-04-21
Classified2025-05-21
Reported by FDA2025-05-28
DistributedNationwide (US)
Quantity262,800
Reason classespackaging
Model numbers386803, 386865

Product

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862

Reason for recall

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

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-1808-2025. 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.