Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics Recalled by Avanos Medical, Inc. Due to Potential for product manifold to crack during use...
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 Avanos Medical, Inc. directly.
Affected Products
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Quantity: 220 units
Why Was This Recalled?
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Avanos Medical, Inc.
Avanos Medical, Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report