Stryker Heavy Duty Sagittal Blades Recall: Potential Sterility Breach Risk
Stryker recalls heavy duty sagittal blades (catalog 6125-127-100) due to potential sterility breach during manufacturing. Affected units may not be sterile, risking infection during surgery.
Lower-risk recall
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Contact the company
What happened, in plain English
Stryker is recalling heavy duty sagittal blades that could have been improperly packaged during manufacturing, potentially compromising sterility. This risk could lead to surgical infections if the blades are used without proper sterility. Read more at govinfonow.com/recall/68607-stryker-heavy-duty-sagittal-blades-recall-potential-sterility-breach-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/68607-stryker-heavy-duty-sagittal-blades-recall-potential-sterility-breach-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1215-2019
Cite this page
“Stryker Heavy Duty Sagittal Blades Recall: Potential Sterility Breach Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68607-stryker-heavy-duty-sagittal-blades-recall-potential-sterility-breach-risk. Based on FDA recall #Z-1215-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2019%22&limit=1).
Why it’s dangerous
During manufacturing, some blades may have had packaging materials improperly positioned, creating a potential breach in sterility. If the blades are used without proper sterility, they could introduce infection during surgery.
Who’s affected
Surgeons using Stryker Heavy Duty Sagittal Blades for orthopedic procedures are affected. Those with the specific catalog number 6125-127-100 and serial number 18247037 are most at risk.
How to tell if you have this one
Check for catalog number 6125-127-100 and serial number 18247037 on the blade packaging. These blades are used in orthopedic surgeries for bone cutting and shaping.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Sterility Status
Verify if the blade has a valid sterility indicator or packaging integrity before use.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA distribution: “US Nationwide in the states of: FL, GA, ID, KY, MA, MD, MN, NC, PA, UT, WA, and WI. The products were distributed to the following foreign countries: Canada, France, Italy, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Idaho, Kentucky, Maryland, Massachusetts, Minnesota, North Carolina, Pennsylvania, Utah, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these blades?
The recall does not require immediate discontinuation; check sterility status before use.
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Where this comes from
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-1215-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1215-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.