The Recall Desk

Manufacturer

SURGIFY MEDICAL OY

19 recalls in our database name SURGIFY MEDICAL OY as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
1
Most recent
2026-07-01

Of the 19 recalls from SURGIFY MEDICAL OY we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • SevereFDA (Devices)·Z-2558-2026·2026-07-01

    Surgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk

    Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.

    Product
    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2026·2026-07-01

    Surgify Halo surgical drill may break during spinal surgery procedures

    Surgify Halo 4.0 mm surgical drills are being recalled because the burr may break during bi-portal endoscopic spinal surgery. The defect could interfere with the surgical procedure.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2026·2026-07-01

    Surgify Halo Surgical Burr Recalled for Breakage Risk

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2026·2026-07-01

    Surgify Halo Spinal Surgery Burrs Recalled for Breakage Risk

    Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2026·2026-07-01

    Surgify Halo surgical drill recalled for potential burr breakage

    Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US states.

    Product
    Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2026·2026-07-01

    Surgify Halo surgical drill equipment recalled for potential burr breakage

    Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.

    Product
    Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2567-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage

    Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. states.

    Product
    Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage during spinal surgery

    Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.

    Product
    Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage during spinal surgery

    Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2026·2026-07-01

    Surgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use

    Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2026·2026-07-01

    Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery

    Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2026·2026-07-01

    Surgify Halo spinal surgery burr tool potential breakage recall

    Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.

    Product
    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2026·2026-07-01

    Surgify Halo Surgical Burr May Break During Spinal Surgery

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2026·2026-07-01

    Surgify Halo Surgical Burr Recalling Potential Tool Breakage Risk

    SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 5.4 mm surgical burrs due to potential breakage during spinal surgery procedures.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2026·2026-07-01

    Surgify Halo Surgical Burrs Subject to Potential Breakage Recall

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2026·2026-07-01

    Surgify Halo Surgical Burrs Recalled Due to Breakage Risk

    SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2026·2026-07-01

    Surgify Halo Surgical Burr Potential Breakage During Endoscopic Spinal Surgery

    Surgify Medical is recalling Surgify Halo 3.0 mm Extendable surgical burrs because they may break during bi-portal endoscopic spinal surgery, posing a risk to patients.

    Product
    Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide