VGI Medical VerteLP Instrument Kit Recalled for Unvalidated Cleaning Process
VGI Medical is recalling six VerteLP Lateral Interbody Fusion instrument kits because the included cleaning process was not validated.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves an unvalidated cleaning process, which is a procedural defect rather than a direct structural failure or reported injury, fitting the Moderate criteria for low-risk contamination or procedural issues without reported harm.
Plain-English summary
VGI Medical, LLC is recalling six units of the VerteLP Lateral Interbody Fusion instrument kit. The recall was initiated because the instruction for use (IFU) contained an automated cleaning process for the VerteLP Instrument Tray that was not validated.
The affected instrument sets include lots LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, and VLP-INSTSET-006. The kits were distributed to facilities in Michigan, Florida, and New York.
Healthcare facilities should stop using the affected instrument kits and contact VGI Medical for further instructions regarding the unvalidated cleaning process.
The recalled product
- Product
- VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Manufacturer
- VGI Medical, LLC
- Hazard
- Affected units
- 6
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 (20)
- Lots of Instrument Sets: LP-INSTSET-001
- VLP-INSTSET-002
- VLP-INSTSET-003
- VLP-INSTSET-004
- VLP-INSTSET-005
- VLP-INSTSET-006. Lots of individual instruments contained in sets: 127617
- 127901
- 127902
- 127903
- 127904
- 127905
- 127906
- 127907
- 127908
- 133003
- 133004
- 133005
- 1330-1
- 1330-2
- 1330-6
Distribution
Related recalls
Other medical device recalls
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighMedline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02