Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DAC 044 115cm Recalled by Stryker Neurovascular Due to Neurovascular devices did not meet the minimum sample...

Date: April 23, 2024
Company: Stryker Neurovascular
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Neurovascular directly.

Affected Products

DAC 044 115cm, Catalog: 90760

Quantity: 81

Why Was This Recalled?

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Neurovascular

Stryker Neurovascular has 108 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report