Stop using nowMedical device recall · FDA · Published February 3, 2023
Avanos Medical: Ballard Access Suction System Elbow Manifold May Crack
Avanos Medical recalls its Ballard Access Closed Suction System elbow manifold for neonates/pediatrics due to potential cracking during use, which could cause leaks and inadequate ventilation. Affected units include specific lot numbers from 2009.
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.
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Contact the company
📍Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894
✎ GovInfoNow plain-language explainer
Avanos Medical is recalling its Ballard Access Closed Suction System elbow manifold for neonates and pediatrics because it can crack during use, potentially causing leaks in the respiratory circuit and leading to inadequate ventilation for patients. This is a serious risk for infants and children in medical settings. Read more at govinfonow.com/recall/58957-avanos-medical-ballard-access-suction-system-elbow-manifold-may-crack.
“Avanos Medical: Ballard Access Suction System Elbow Manifold May Crack.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58957-avanos-medical-ballard-access-suction-system-elbow-manifold-may-crack. Based on FDA recall #Z-1190-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1190-2023%22&limit=1).
The FDA announced on Feb. 3, 2023, that Avanos Medical, Inc. is recalling BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics Elbow Manifolds due to potential cracking. The hazard involves possible leaks in the respiratory circuit leading to inadequate patient ventilation.
How to tell if you have it
Brand: Avanos Medical
Product: BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold
Distribution: US Nationwide distribution in the state of Oklahoma
The hazard
The product manifold may crack during use on patients, possibly causing leaks in the respiratory circuit. This can lead to the patient receiving inadequate ventilation.
Context
GovInfoNow's records show Avanos Medical, Inc. has 18 other recalls on record since 2019-10-08. Other recent recalls of similar products include Avanos CORFLO Safety PEG Kit with ENFit Connector (2026-04-30), Ballard Closed Suction Catheters (2025-03-19), and Avanos MIC-KEY Gastric-Jejunal Feeding Tube Kit (2024-05-31). Other recent recalls of similar products include Merit Medical Custom Manifold Kit (2025-12-04), Aju Pharm AlternatiV+ Screw-In Anchor (2025-12-17), and Argon Medical Devices L-Cath Midline Catheter (2026-06-15).
How to tell if you have this one
Check for the specific lot numbers: B50511 (20098277), B50611 (20098278), B50711 (20098279), or B50811 (20097177, 20097177R1). The product is sold for neonatal and pediatric use.
Brand
Avanos Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
US Nationwide distribution in the state of Oklahoma.
Recall number
Product, codes & lots
Quantity
Z-1189-2023
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.; All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
780 units
Z-1190-2023
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.; All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).
220 units
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the affected Ballard Access Closed Suction System elbow manifold as it can crack during use, potentially causing leaks and inadequate ventilation.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Oklahoma.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1190-2023 (February 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1190-2023 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.