Use cautionMedical device recall · FDA · Published September 5, 2024
Stryker 1.2mm Cross Cut Fissure Recall: Endotoxin Risk in Neurosurgery
Stryker recalls 1.2mm Cross Cut Fissure surgical tools due to potential endotoxin levels causing fever, inflammation, and meningitis in neurosurgical procedures. Affected items have specific catalog and lot numbers.
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Take action
Contact the company
📍Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711
✎ GovInfoNow plain-language explainer
Stryker is recalling 1.2mm Cross Cut Fissure surgical tools that may contain endotoxins high enough to cause fever, inflammation, or meningitis during neurosurgery. This risk is highest for patients undergoing spinal or neurosurgical procedures. Read more at govinfonow.com/recall/54070-stryker-1-2mm-cross-cut-fissure-recall-endotoxin-risk-in.
“Stryker 1.2mm Cross Cut Fissure Recall: Endotoxin Risk in Neurosurgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54070-stryker-1-2mm-cross-cut-fissure-recall-endotoxin-risk-in. Based on FDA recall #Z-0063-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0063-2025%22&limit=1).
The FDA announced on September 5, 2024, that Stryker Corporation is recalling 307 units of its 1.2mm Cross Cut Fissure surgical instruments due to potential endotoxin contamination. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Brand: Stryker
Product: 1.2mm Cross Cut Fissure
Catalog Number: 5820-066-012
GTIN/UPC: 04546540362346
Lot number: 22329017
The hazard
The devices may exhibit endotoxin levels greater than 2.15 EU per device, which can cause fever and inflammation upon exposure. Meningitis may occur if there is contact with cerebrospinal fluid, making neurosurgical and spinal procedures a population at greatest risk.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Other recent recalls of similar products include Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk (June 17, 2026), AMD Medicom Ritmed Neurological Sponges Recall: Endotoxin Risk in Surgery (May 8, 2026), and Medline Spinal Fusion Kits Recall: High Endotoxin Levels in Neuro Sponges (March 19, 2026).
How to tell if you have this one
Check for catalog number 5820-066-012 and lot number 22329017 on the product packaging. These tools were sold in dental, ENT, neuro, and spine procedures.
Brand
Stryker
Product
1.2mm Cross Cut Fissure
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog number 5820-066-012 and lot number 22329017 on the packaging to confirm if the item is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Columbia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0063-2025 (September 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0063-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.