HIGH

B Braun Medical Recalls Anesthesia Tray Over Connector Risk

B Braun Medical recalled 60 units of its Combined Spinal and Epidural Anesthesia Tray on September 18, 2025. The recall stems from the potential for the lid of the catheter connector to be incorrectly positioned. Healthcare providers must stop using the device immediately and follow manufacturer instructions.

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 Combined Spinal and Epidural Anesthesia Tray 2, featuring a PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a PENCAN 27 Ga. x 5 in. Spinal Needle. Product Code: SESK, Lot Number: 0062003227, with an expiration date of July 31, 2026.

The Hazard

The primary concern is the incorrect positioning of the catheter connector lid, which can lead to complications during anesthesia procedures. This issue poses a high risk to patient safety.

Reported Incidents

No specific incidents or injuries have been reported as a result of this defect. However, the potential risk remains significant due to the nature of the medical device.

What to Do

Patients and healthcare providers should stop using the device immediately. They should contact B Braun Medical Inc or their healthcare provider for further instructions regarding the recall.

Contact Information

For additional information, contact B Braun Medical Inc. Visit the FDA recall page for more details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0125-2026.

Key Facts

  • Recall date: September 18, 2025
  • Quantity recalled: 60 units
  • Distribution: Nationwide
  • Classification: Class II
  • Expiration Date: July 31, 2026
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeAnesthesia Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
REF: 530185
Product Code: SESK
UDI-DI (Primary): 04046955625147
UDI-DI (Unit of Use): 04046955625130
Lot Number: 0062003227
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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