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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

Globus Medical, Inc.: ExcelsiusGPS Cannula A Recalled for Sterility and Infection Risk

Agency Publication Date: February 7, 2024
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Summary

Globus Medical, Inc. is recalling 570 units of the ExcelsiusGPS Cannula A (Model No. 6143.2844) because of a defect where an internal gap may prevent the device from being properly cleaned. This manufacturing issue makes it difficult to effectively remove debris or contaminants prior to steam sterilization. These surgical instruments are used with ball tip probes and were distributed worldwide, including across the United States. Consumers should contact their healthcare provider or the manufacturer regarding these devices.

Risk

The internal gap in the device can trap organic material, making it difficult to clean and sanitize. This poses a significant risk of infection, cross-contamination between patients, local or systemic toxicity, and inflammation during medical procedures.

What You Should Do

  1. Identify if your facility has the ExcelsiusGPS Cannula A, 9mm x 250mm, Model No. 6143.2844, with UDI-DI 00889095998498.
  2. Check your device for the following specific affected lot numbers: FSB136AA, FSB121AA, FSB241AA, FSB207AA, FSB110AA, FSB073AA, FSA286CA, FSA286BA, FSA286AA, FSA263DA, FSA263EA, FSA263CA, FSA263AA, FSA263BA, FSA160AA, FSA160BA, FSA105BA, FSA105AA, FSA053AA, FSY319AA, FSY279BA, FSY279AA, FSY272AA, FSY230AA, FSY098AA, FSY098CA, FSY098BA, FSY048AA, FSX093AA, FSX205AA, FSX141BA, FSX141CA, FSX141AA, FSX063AA, FSX041AA, FSX041BA, FSW142AA, or FSW094AA.
  3. Contact your healthcare provider or Globus Medical, Inc. at their Audubon, Pennsylvania headquarters for specific instructions on returning or replacing these instruments.
  4. Healthcare professionals should immediately sequester any affected units to prevent their use in surgical procedures.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ExcelsiusGPS Cannula A, 9mm x 250mm
Model / REF:
6143.2844
UPC Codes:
00889095998498
Lot Numbers:
FSB136AA
FSB121AA
FSB241AA
FSB207AA
FSB110AA
FSB073AA
FSA286CA
FSA286BA
FSA286AA
FSA263DA
FSA263EA
FSA263CA
FSA263AA
FSA263BA
FSA160AA
FSA160BA
FSA105BA
FSA105AA
FSA053AA
FSY319AA
FSY279BA
FSY279AA
FSY272AA
FSY230AA
FSY098AA
FSY098CA
FSY098BA
FSY048AA
FSX093AA
FSX205AA
FSX141BA
FSX141CA
FSX141AA
FSX063AA
FSX041AA
FSX041BA
FSW142AA
FSW094AA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93804
Status: Active
Manufacturer: Globus Medical, Inc.
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 570
Distributed To: Nationwide

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.