Avanos Medical, Inc. recall records

35 reported ongoing

52 records in this archive. Latest source date Apr 30, 2026. 1 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediat...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Ver...
FDA device enforcement

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediat...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Ver...
FDA device enforcement

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pedi...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software V...
FDA device enforcement

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...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software ...
FDA device enforcement

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...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software ...
FDA device enforcement

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction Syste...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Softwa...
FDA device enforcement

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 fo...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software V...
FDA device enforcement

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction Syst...

Lack of sterility assurance for closed suction catheter systems

Class IReported ongoing

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, ...

Official source for Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Softw...
FDA device enforcement

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extensi...

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.

Official source for MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube...
FDA device enforcement

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber Non...

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Official source for NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral...
FDA device enforcement

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSt...

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Official source for NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral...
FDA device enforcement

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange No...

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Official source for NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral ...
FDA device enforcement

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 82...

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH,...

Official source for MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit...
FDA device enforcement

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 025...

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH,...

Official source for MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jeju...
FDA device enforcement

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

Class IIReported ongoing

Distribution: US and South Africa

Official source for AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide su...
FDA device enforcement

COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The sys...

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

Class IIReported completed

Distribution: US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL

Official source for COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channe...

Reasons in these listed records

  • Lack of sterility assurance for closed suction catheter systems
  • The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
  • The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
  • Potential Lack of Sterility Assurance

These examples come from this result page and are not a ranking of every recall reason.

Checking Avanos Medical, Inc.

Is there a recall on avanos medical, inc. right now?

This archive contains 52 records, including 35 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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