Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- B BRAUN MEDICAL
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- B BRAUN MEDICAL
- Product type
- Combined Spinal and Epidural Anesthesia Tray
- Model numbers
- REF: 530185, Product Code SESK, UDI-DI (Primary): 04046955625147, UDI-DI (Unit of Use): 04046955625130, Lot Number: 0062003227
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
This product is a spinal and epidural anesthesia tray used in surgical settings to administer anesthetic throughout spinal and epidural procedures.
Why This Is Dangerous
An incorrect lid position on the catheter connector can compromise the integrity of the connection and delivery path for anesthetic drugs.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
No injuries reported yet; highest risk is improper administration of anesthesia if used with a mispositioned lid.
Practical Guidance
How to identify if yours is affected
- Verify Product Code SESK.
- Check UDI-DI 04046955625147 (Primary) and 04046955625130 (Unit of Use).
- Inspect Lot Number 0062003227.
- Confirm model references REF: 530185.
Where to find product info
UDI labels on the packaging and the product itself; look for Product Code SESK and Lot 0062003227.
What timeline to expect
Remedies and replacement process will be communicated by the manufacturer; typical timelines vary by facility.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Contact hospital risk management for guidance.
- File recall with the appropriate regulatory body if needed.
How to prevent similar issues
- Verify tray compatibility before use.
- Maintain strict inventory controls to isolate recalled lots.
- Stay updated with manufacturer recall notices.
Documentation advice
Keep copies of the recall notice, purchase records, and all correspondence with the manufacturer.
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Product Details
Product: SESK Combined Spinal and Epidural Tray 2. Includes PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Code: SESK. UDI-DI 04046955625147. Unit of Use: 04046955625130. Lot Number: 0062003227. Quantity: 60 units. Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Reported Incidents
No specific injuries or adverse events are detailed in the recall notice. The status is active with a high-hazard designation.
Key Facts
- 60 units recalled nationwide
- Product Code SESK with UDI-DI 04046955625147
- Hazard: Catheter connector lid position may be incorrect
- Recall date 2025-09-18, report date 2025-10-15
- Active recall status, high hazard level
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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