CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
ExcelsiusGPS Cannula A, Cannula used with ball tip probes recalled
Globus Medical is recalling ExcelsiusGPS Cannula A, Cannula used with ball tip probes, distributed nationwide in the US. The recall was initiated on 15 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1007-2024
- FDA event ID
- 93804
- Recalling firm
- Globus Medical, Audubon, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2023
- FDA classified
- 7 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 15 Dec 2023 | Recall initiated by company | |
| 7 Feb 2024 | Classified by FDA | +54 days |
| 14 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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