SURGIFY MEDICAL OY 2026-07-01 Health serious FDA
Health · FDA · Recall #FDA-Z-2568-2026
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &… Recall
Issued July 1, 2026 · SURGIFY MEDICAL OY
In July 2026, SURGIFY MEDICAL OY recalled the Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &…, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What you should do
- 1 Stop using Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SURGIFY MEDICAL OY to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SURGIFY MEDICAL OY
- Category
- Health
- Recall date
- July 1, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Recall number
- FDA-Z-2568-2026
- Made in
- Finland
- Issuing agency
- FDA
In context
- SURGIFY MEDICAL OY has 2 recalls in our database.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.