ExcelsiusGPS Cannula A — Class II medical device recall Z-1007-2024
Ongoing recall by Globus Medical, Inc., reported 2024-02-14, distributed nationwide. Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increas
| Recall number | Z-1007-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Globus Medical, Inc., Audubon, PA, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CZ, DE, ES, GB, ID, IE, IN, IT, JP, MY, NL, PL, SA, SG |
| Quantity | 570 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00889095998498 |
| Lot numbers | FSA053AA, FSA105AA, FSA105BA, FSA160AA, FSA160BA, FSA263AA, FSA263BA, FSA263CA, FSA263DA, FSA263EA, FSA286AA, FSA286BA, FSA286CA, FSB073AA, FSB110AA, FSB121AA, FSB136AA, FSB207AA, FSB241AA, FSW094AA, FSW142AA, FSX041AA, FSX041BA, FSX063AA, FSX093AA, FSX141AA, FSX141BA, FSX141CA, FSX205AA, FSY048AA, FSY098AA, FSY098BA, FSY098CA, FSY230AA, FSY272AA, FSY279AA, FSY279BA, FSY319AA |
| Model numbers | 6143.2844 |
Product
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1007-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.