Globus Medical, Inc.
Complete recall history across all FDA and CPSC categories — 29 total recalls
Globus Medical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (29)
FDA medical device enforcement actions by Globus Medical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 3, 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Devices for the affected lot were not assembled according to product specifi... | Class II |
| Dec 15, 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... | Devices may not be rendered sterile due to an internal gap that may be presen... | Class II |
| Dec 11, 2023 | Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packa... | Class II |
| Dec 11, 2023 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packa... | Class II |
| Dec 11, 2023 | Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packa... | Class II |
| Dec 7, 2023 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | A calibration error associated with the Flat Panel Fluoroscopy Fixture when u... | Class I |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been... | Class II |
| Aug 28, 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ... | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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