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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

B. Braun Combined Spinal/Epidural Trays Recalled for Incorrect Connectors

Agency Publication Date: January 24, 2025
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Summary

B. Braun Medical, Inc. has recalled 1,090 units of its Design Options Combined Spinal/Epidural Trays due to an incorrect catheter connector included in the kit. The connector provided is smaller than required, which prevents a secure connection to the epidural catheter and makes it impossible to administer medication. These trays are intended for the administration of anesthetic or analgesic agents to the spinal or epidural space for pain control.

Risk

The incorrect connector size results in an inability to securely connect to the catheter, leading to the failure of medication delivery during medical procedures. While no injuries have been reported, this defect prevents the device from performing its intended function of pain management.

What You Should Do

  1. This recall affects B. Braun Design Options Combined Spinal/Epidural Trays with Model/Catalog Number 530159 and Lot Number 0061916572.
  2. Stop using the recalled device immediately.
  3. Contact B. Braun Medical, Inc. or your medical distributor to arrange for the return, replacement, or correction of the affected product.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Design Options COMBINED SPINAL/EPIDURAL TRAY
Model / REF:
530159
Lot Numbers:
0061916572
UDI:
04046964669286
04046964669279

Recall Number: Z-1021-2025; Primary UDI-DI 04046964669286; Unit of Use UDI-DI 04046964669279

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95874
Status: Active
Manufacturer: B. Braun Medical, Inc.
Sold By: Healthcare facilities; Medical distributors
Manufactured In: United States
Units Affected: 1090 units
Distributed To: Missouri, Oklahoma

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.