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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.: Cranial Drills Recalled for Potential Loss of Sterility and Discoloration

Agency Publication Date: February 6, 2024
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Summary

Globus Medical is recalling several models of sterile-packed Cranial Drills used with the ExcelsiusGPS system because the packaging may be breached, potentially compromising the sterility of the instruments. Additionally, some drill tips may show signs of discoloration. This recall affects various 2.40mm, 3.20mm, and 6.00mm drills distributed worldwide, including throughout the United States, Czech Republic, and Poland.

Risk

A breach in sterile packaging can expose surgical instruments to bacteria and other contaminants, which may lead to serious infections during cranial procedures. Discoloration on the drill tip may also indicate material issues that could affect the performance or safety of the device during surgery.

What You Should Do

  1. Identify if you have any of the affected Globus Medical Cranial Drills by checking the Reference numbers: 6143.1834S (2.40mm), 6143.1842S (3.20mm), or 6143.1870S (6.00mm).
  2. Locate the UDI/Lot information on the packaging to confirm if your specific unit is affected; specific codes include GBB156EB, GBY098JA, GBY098HA, GBY097FA, GBY097VA, GBY097RA, GBY097JA, GBY097HA, GBY097GA, GBY094NA, GBY094MA, GBY094JA, GBY094HA, GBY093XA, and GBY093VA (including those with -RB suffixes).
  3. Immediately stop using any drills from the affected lots and quarantine them to ensure they are not used in surgical procedures.
  4. Contact your healthcare provider or Globus Medical, Inc. directly for specific instructions on returning the affected products and obtaining replacements.
  5. For additional information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return product to manufacturer.

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

Affected Products

Product: Globus Medical Cranial Drill with Stop, 2.40mm
Model / REF:
6143.1834S
Lot Numbers:
GBB156EB
GBY098JA
GBY098HA
GBY097FA
GBY098JA-RB
GBY098HA-RB
GBY097FA-RB
Product: Globus Medical Cranial Drill with Stop, 3.20mm
Model / REF:
6143.1842S
Lot Numbers:
GBY097VA
GBY097RA
GBY097JA
GBY097HA
GBY097GA
GBY097VA-RB
GBY097RA-RB
GBY097JA-RB
GBY097HA-RB
GBY097GA-RB
Product: Globus Medical Cranial Drill, 6.00mm
Model / REF:
6143.1870S
Lot Numbers:
GBY094NA
GBY094MA
GBY094JA
GBY094HA
GBY093XA
GBY093VA
GBY094NA-RB
GBY094MA-RB
GBY094JA-RB
GBY094HA-RB
GBY093XA-RB
GBY093VA-RB

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93742
Status: Active
Manufacturer: Globus Medical, Inc.
Sold By: Authorized Medical Distributors; Direct Sales to Hospitals
Manufactured In: United States
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.

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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.