CLASS I Device recall · Reported 22 Mar 2023 · FDA Enforcement Report

Ballard* Access Closed Suction System recalled by Avanos Medical

Avanos Medical is recalling Ballard* Access Closed Suction System for Neonates/Pediatrics, Elbow Manifold, distributed nationwide in the US. The recall was initiated on 3 Feb 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).

Quantity recalled220 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1190-2023
FDA event ID: 91663
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class I
Status: Terminated
Recall initiated: 3 Feb 2023
FDA classified: 13 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

3 Feb 2023	Recall initiated by company
13 Mar 2023	Classified by FDA	+38 days
22 Mar 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

Where it was distributed

US Nationwide distribution in the state of Oklahoma.

Nationwide Oklahoma

Stores named: Walmart

Questions about this recall

Is Ballard* Access Closed Suction System for Neonates/Pediatrics, Elbow Manifold recalled?

Yes. Avanos Medical recalled Ballard* Access Closed Suction System for Neonates/Pediatrics, Elbow Manifold on 3 Feb 2023. The recall is Class I and its status is Terminated. Recall number Z-1190-2023.

Why was it 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.

Which lots are affected?

All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).

Where was it sold?

US Nationwide distribution in the state of Oklahoma.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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