Device recall: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product…

Class I FDA enforcement event 96528. Recall start date: 19 Mar 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Lack of sterility assurance for closed suction catheter systems

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Avanos Medical, Inc. started this device recall on 19 Mar 2025. The firm address in the FDA record is in Alpharetta, GA. FDA put the recall in Class I. FDA event 96528 has 8 product records. The first FDA enforcement report date is 23 Apr 2025. The record gives the status Ongoing.

FDA enforcement report The 8 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA,…

Recalling firm

Avanos Medical, Inc., Alpharetta, GA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

8 product records in the event.

FDA event 96528: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1521-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No	1980 units	Class I	Ongoing	23 Apr 2025
Z-1522-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A	4000 units	Class I	Ongoing	23 Apr 2025
Z-1523-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A	9960 units	Class I	Ongoing	23 Apr 2025
Z-1524-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A	9020 units	Class I	Ongoing	23 Apr 2025
Z-1525-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A	2080 units	Class I	Ongoing	23 Apr 2025
Z-1526-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A	1420 units	Class I	Ongoing	23 Apr 2025
Z-1527-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A	1040 units	Class I	Ongoing	23 Apr 2025
Z-1528-2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A	0	Class I	Ongoing	23 Apr 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class I: 13%
Product records in this event: 8Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Avanos Medical, Inc.
Initiated	Product (first record)	Type	Class	Records
30 Apr 2026	Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320	Device	Class II	20
31 May 2024	MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT	Device	Class II	1
4 Mar 2024	NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSteri	Device	Class III	3
16 Jan 2024	MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector -	Device	Class I	2
13 Oct 2023	AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me	Device	Class II	1
1 Aug 2023	COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha	Device	Class II	1
24 Apr 2023	AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509	Device	Class II	5
3 Feb 2023	Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251	Device	Class II	1
3 Feb 2023	BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.	Device	Class I	2
14 Sep 2022	Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUM	Device	Class II	1

Avanos Medical, Inc.: all 19 events

Official channels

FDA enforcement report Z-1521-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 96528. https://recallregister.com/fda/i/96528/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA,…
What quantity of product is in FDA event 96528?: The event has 8 product records. The first record gives this quantity: 1980 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 13% of the 945 device events that started in 2025 are in Class I.