ESPOCAN Spinal-Epidural Anesthesia Tray Recalled for Catheter Connector Positioning Defect
B. Braun Medical Inc. recalls ESPOCAN Combined Spinal and Epidural Anesthesia Trays nationwide due to potential catheter connector lid misalignment that could affect anesthetic administration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall without reported illnesses or injuries. The hazard is theoretical—a catheter connector lid in incorrect position—making this a risk-of-harm product where injury has not yet been reported, per the rubric's criterion for High severity.
Plain-English summary
B. Braun Medical Inc. is recalling the ESPOCAN Combined Spinal and Epidural Anesthesia Tray with ESPOCAN Tuohy Epidural Needle, PENCAN Spinal Needle, and PERIFIX FX Epidural Catheter (Product Code ES1725KFX). Approximately 10,130 units have been distributed nationwide across all U.S. states.
The recall was initiated because the lid of the catheter connector may be positioned incorrectly. This defect could affect the proper assembly and function of the anesthesia catheter, potentially compromising the safe administration of spinal and epidural anesthesia.
The affected lot numbers are 0062005817, 0062011662, 0062011663, 0062014354, and 0062011664, with an expiration date of July 31, 2026. Healthcare facilities and anesthesia providers who have received affected trays should discontinue use immediately and contact B. Braun Medical Inc. for guidance on replacement or return. Do not use any units from the affected lots.
The recalled product
- 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: ES1725KF
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- assembly-defect
- catheter-connector-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- REF: 333196
- Product Code: ES1725KFX
- UDI-DI (Primary): 04046955899531
- UDI-DI (Unit of Use): 04046955899548
- Lot Numbers: 0062005817
- 0062011662
- 0062011663
- 0062014354
- 0062011664. Expiration Date: 07/31/2026.
Distribution
Distributed nationwide across the United States.
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