FDA Device recall Z-1808-2025
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865 by Becton Dickinson Infusion Therapy Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1808-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-21 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson Infusion Therapy Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027 |
|---|
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-1808-2025%22
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