Recall Z-0122-2026— B BRAUN MEDICAL INC

Class II · Ongoing

Class II FDA medical device recall by B BRAUN MEDICAL INC, initiated 2025-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.. Reason: Potential for the lid of the catheter connector to be in the incorrect position..

Recalling firm
B BRAUN MEDICAL INC
Classification
Class II
Status
Ongoing
Initiated
2025-09-18
Firm location
Allentown, PA, United States

Product description

ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.

Reason for recall

Potential for the lid of the catheter connector to be in the incorrect position.

Data sourced from openFDA. This site is unofficial and independent of the FDA.