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, PETS
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
- Spinal/Epidural Anesthesia Tray and Needle Kit
- Model numbers
- ES1725KFX, REF: 333196, UDI-DI 04046955899531, UDI-DI (Unit of Use) 04046955899548, Lot 0062005817, Lot 0062011662, 0062011663, 0062014354 +1 more
- 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
ESPOCAN tray systems are used to perform combined spinal and epidural anesthesia procedures. They enable precise needle placement and catheter connection in a single setup.
Why This Is Dangerous
A lid-position error in the catheter connector can compromise the integrity of the connection, potentially impacting patient safety during anesthesia.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics must halt use of affected trays and follow recall instructions, which may affect scheduling and procurement.
Practical Guidance
How to identify if yours is affected
- Check product code ES1725KFX and UDI numbers 04046955899531 and 04046955899548
- Verify packaging labeling matches the recalled product description
Where to find product info
Look on the device label for product code and UDI numbers; recall letters provide full guidance
What timeline to expect
Remedies are issued per recall procedures; facilities should expect guidance from the manufacturer and regulatory bodies
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- Escalate to hospital risk management or regulatory authorities if no response within 2 weeks
How to prevent similar issues
- Verify product code and UDI before use
- Use only trays from authorized distributors
- Maintain a recall readiness plan for medical devices
- Review vendor recall communications for updates
Documentation advice
Keep copy of recall notice, product labels, lot numbers, and correspondence with the manufacturer
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Product Details
Brand: B BRAUN MEDICAL. Product: ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. Spinal Needle with Marking and Centering Sleeve, and 19 Ga. closed-tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. UDI-DI (Primary): 04046955899531. UDI-DI (Unit of Use): 04046955899548. Lot Numbers: 0062005817, 0062011662, 0062011663, 0062014354, 0062011664. 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
Reported Incidents
No incidents or injuries are reported in the provided data.
Key Facts
- Product Code ES1725KFX
- Nationwide distribution to 50 states and territories
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Safety Guide
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