Stryker AXS Infinity LS Long Sheath Recall: Outer Diameter Issue
Stryker recalls specific AXS Infinity LS Long Sheath models due to outer diameter specification being exceeded. Affected units include GEN-10800-70, GEN-10800-80, and GEN-10800-90 models. No remedy is stated in the recall notice.
Recall notice
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Contact the company
What happened, in plain English
Stryker is recalling certain AXS Infinity LS Long Sheath models because the outer diameter specification was exceeded. This could lead to improper function during medical procedures. Affected units are identified by specific model numbers and lot numbers. Read more at govinfonow.com/recall/71220-stryker-axs-infinity-ls-long-sheath-recall-outer-diameter-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/71220-stryker-axs-infinity-ls-long-sheath-recall-outer-diameter-issue · Updated August 21, 2026 · FDA enforcement record: FDA #Z-3281-2018
Cite this page
“Stryker AXS Infinity LS Long Sheath Recall: Outer Diameter Issue.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71220-stryker-axs-infinity-ls-long-sheath-recall-outer-diameter-issue. Based on FDA recall #Z-3281-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3281-2018%22&limit=1).
Why it’s dangerous
The outer diameter specification being exceeded means the sheath may not fit properly during medical procedures. This could cause complications such as tissue damage or improper device function. The hazard is specific to the medical context where precise sizing is critical.
Who’s affected
Medical professionals using the AXS Infinity LS Long Sheath system are likely affected. Patients undergoing procedures with these sheaths may be at risk if the device malfunctions.
How to tell if you have this one
Check for model numbers GEN-10800-70, GEN-10800-80, or GEN-10800-90 on the sheath packaging. The lot number 20156091 and unique identifier UDI (01)07613327298253 are also associated with affected units.
- Brand
Stryker- Product
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number and lot number on the sheath packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, New Jersey, New York, Ohio, Pennsylvania, West Virginia.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-3281-2018 (May 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3281-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 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.