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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 1, 2026

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1

Full official product description

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered) | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered) | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered); Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered); plus 10 additional official variants listed below.

Identifiers to compare

  • UDI 06429811532120
  • UDI 06429811532076
  • UDI 06429811532083
  • UDI 06429811532267
  • UDI 06429811532137
  • UDI 06429811532311
  • UDI 06429811532090
  • UDI 06429811532212
  • UDI 06429811532281
  • UDI 06429811532106
  • UDI 06429811532205
  • UDI 06429830116998
  • Lot until

12 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)UDI: 06429811532120 ; All lots until the IFU update has been implementedN/AZ-2568-2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532076; All lots until the IFU update has been implemented112 unitsZ-2558-2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532083; All lots until the IFU update has been implemented0Z-2562-2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532267; All lots until the IFU update has been implementedN/AZ-2561-2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532137 ; All lots until the IFU update has been implementedN/AZ-2572-2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532311 ; All lots until the IFU update has been implemented8 unitsZ-2565-2026
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532090 ; All lots until the IFU update has been implementedN/AZ-2566-2026
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532212; All lots until the IFU update has been implementedN/AZ-2557-2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532281; All lots until the IFU update has been implementedN/AZ-2559-2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532106 ; All lots until the IFU update has been implementedN/AZ-2570-2026
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)UDI: 06429811532205; All lots until the IFU update has been implementedN/AZ-2556-2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)UDI: 06429830116998 ; All lots until the IFU update has been implemented53 unitsZ-2564-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.