FDA recall, , Moderate risk
Surgify Halo Surgical Drills and Burrs
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Summary by Recall Canary from the FDA notice
What happened
SURGIFY MEDICAL OY of Espoo, Finland, recalled Surgify Halo burrs, trephines and accessories used in bi-portal endoscopic spinal surgery (BESS) due to potential for burr breakage. The FDA added the recall to its Enforcement Report on June 24, 2026, after the company began the recall on April 30, 2026. The products were distributed in the states of MN, MA, IN, LA, CA, NY, FL.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
19 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532076
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532120
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532267
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532137
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532083
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532311
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532090
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532281
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532212
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532106
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429830116998
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532205
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532328
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532229
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532335
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532298
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532274
- Lot code
- All lots until the IFU update has been implemented
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- UDI-DI
- 06429811532304
- Lot code
- All lots until the IFU update has been implemented
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, Florida.
- Company
- SURGIFY MEDICAL OYEspoo, Finland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98918
- Recall numbers
- Z-2555-2026 to Z-2573-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
