FDA Device recall Z-0125-2026
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm)…
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm)… by B Braun Medical, citing potential for the lid of the catheter connector to be in the incorrect position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0125-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-18 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Reason
Potential for the lid of the catheter connector to be in the incorrect position.
Identifiers
| code_info | REF: 530185; Product Code: SESK; UDI-DI (Primary): 04046955625147; UDI-DI (Unit of Use): 04046955625130; Lot Number: 0062003227. Expiration Date: 07/31/2026. |
|---|
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-0125-2026%22
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