Recall archive / FDA device enforcement
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 — FDA record Z-1007-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
- Reason
- Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
- Classification
- Class II
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 570
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1007-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00889095998498 Lots FSB136AA FSB121AA FSB241AA FSB207AA FSB136AA FSB121AA 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 FSX093AA FSX063AA FSX041AA FSX041BA FSW142AA FSW094AA |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Czech Republic, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Singapore, Spain, United Arab Emirates, United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Dec 15, 2023
- Center classification date
- Feb 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.