Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: Recalled by Intersurgical Inc Due to A defect in the wire-reinforced tubing may result...
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 Intersurgical Inc directly.
Affected Products
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
Quantity: 144 cases / 20 units
Why Was This Recalled?
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Where Was This Sold?
This product was distributed to 5 states: IL, KY, NY, OH, VA
About Intersurgical Inc
Intersurgical Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report