Stryker Neurovascular Distal Access Catheter Recall: Out-of-Spec Endotoxin Risk
Stryker Neurovascular recalls Distal Access Catheter (Lot #0000486382) due to out-of-specification endotoxin results. Affected units may pose a risk of infection or adverse reactions. Consumers should contact Stryker for details.
Lower-risk recall
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Contact the company
What happened, in plain English
Stryker Neurovascular is recalling a specific Distal Access Catheter model due to endotoxin levels that were outside acceptable specifications. This could potentially lead to infection or adverse reactions if used in medical procedures. Read more at govinfonow.com/recall/55669-stryker-neurovascular-distal-access-catheter-recall-out-of-spec-endotoxin.
Source Summary by GovInfoNow · govinfonow.com/recall/55669-stryker-neurovascular-distal-access-catheter-recall-out-of-spec-endotoxin · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1740-2024
Cite this page
“Stryker Neurovascular Distal Access Catheter Recall: Out-of-Spec Endotoxin Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55669-stryker-neurovascular-distal-access-catheter-recall-out-of-spec-endotoxin. Based on FDA recall #Z-1740-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2024%22&limit=1).
Why it’s dangerous
The catheter was manufactured with endotoxin levels outside the specified range. Endotoxins are bacterial components that can cause infections or adverse reactions when introduced into the body during medical procedures.
Who’s affected
Healthcare professionals using the recalled Distal Access Catheter for medical procedures are most at risk. Patients receiving procedures with this catheter may also be affected.
How to tell if you have this one
Check for the UDI-DI: 07613327313895 and Lot number 0000486382 on the product label. The catheter has a hydrophilic coating and a rotating hemostasis valve with side-arm adapter.
- Brand
Stryker Neurovascular- Category
Medical device
What to do — step by step
Contact Stryker
Reach out to Stryker Neurovascular for specific instructions on how to return or dispose of the recalled catheter.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
FDA distribution: “US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Colorado, Florida, Illinois, Louisiana, Michigan, Mississippi, New Jersey, North Carolina, Pennsylvania, South Carolina, Texas.
Recall timeline
FDA published this recall 35 days 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.
Questions people ask
Is there a risk of serious injury from this catheter?
The recall is due to potential infection or adverse reactions, not immediate serious injury risks. The danger level is low risk.
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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-1740-2024 (April 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1740-2024 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.