Globus Medical Cranial Drill recalled for potential sterility compromise
Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device where sterility compromise in surgical instruments poses a risk of infection. No illnesses or injuries have been reported. This meets the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling Cranial Drills with Stop, 3.20mm, which are used for cranial device access, preparation, and placement with the ExcelsiusGPS system.
Sterile-packed drills in this recall may not be sterile due to breaches in packaging and/or may have discoloration near the drill tip. These defects could impact instrument integrity during surgical use.
The recall affects devices distributed worldwide, including the United States, Czech Republic, and Poland. Affected devices can be identified by their UDI codes listed in the FDA recall notice.
The recalled product
- Product
- Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
- Manufacturer
- Globus Medical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot: UDI: GBY097VA (01)00193982302269(17)280313(10)GBY097VA
- GBY097RA (01)00193982302269(17)280313(10)GBY097RA
- GBY097JA (01)00193982302269(17)280313(10)GBY097JA
- GBY097HA (01)00193982302269(17)280313(10)GBY097HA
- GBY097GA (01)00193982302269(17)280313(10)GBY097GA
- GBY097VA-RB (01)00193982302269(17)280313(10)GBY097VA-RB
- GBY097RA-RB (01)00193982302269(17)280313(10)GBY097RA-RB
- GBY097JA-RB (01)00193982302269(17)280313(10)GBY097JA-RB
- GBY097HA-RB (01)00193982302269(17)280313(10)GBY097HA-RB
- GBY097GA-RB (01)00193982302269(17)280313(10)GBY097GA-RB
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Globus Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Globus Medical, Inc.
See all →- HighGlobus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly
FDA (Devices) · 2025-04-30
- HighGlobus Medical Cranial Drills recalled for sterility loss and discoloration
FDA (Devices) · 2024-02-14
- HighGlobus Medical Cannula May Not Be Properly Sterilized
FDA (Devices) · 2024-02-14
- HighGlobus Medical Cranial Drill recalled for sterility breach risk
FDA (Devices) · 2024-02-14
- HighExcelsiusGPS surgical navigation system calibration error may cause device misplacement
FDA (Devices) · 2024-01-24
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12