HIGH

B Braun Medical Recalls Epidural Anesthesia Tray Over Hazard

B Braun Medical recalled 10,130 units of its Combined Spinal and Epidural Anesthesia Tray on September 18, 2025. The recall affects devices due to a potential misalignment with the catheter connector lid. Healthcare providers and patients must stop using the product immediately.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
B BRAUN MEDICAL
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall includes the ESPOCAN Combined Spinal and Epidural Anesthesia Tray, featuring a 17 Ga. x 3-1/2 in. Tuohy epidural needle and a PENCAN 25 Ga. x 5 in. spinal needle. The product code is ES1725KFX and it was distributed nationwide.

The Hazard

The hazard involves the lid of the catheter connector possibly being in the incorrect position. This misalignment can lead to serious complications during anesthesia administration.

Reported Incidents

No specific incidents or injuries have been reported in relation to this recall. However, the potential for improper catheter function poses a significant risk.

What to Do

Patients and healthcare providers should stop using the affected device immediately. Contact B Braun Medical or your healthcare provider for further instructions on the recall.

Contact Information

Phone: 1-800-xxx-xxxx. For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0122-2026.

Key Facts

  • Recall date: September 18, 2025
  • Quantity recalled: 10,130 units
  • Class: II
  • Hazard level: High
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeEpidural Anesthesia Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
REF: 333196
Product Code: ES1725KFX
UDI-DI (Primary): 04046955899531
UDI-DI (Unit of Use): 04046955899548
Lot Numbers: 0062005817
+4 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more