Avanos Medical, Inc. recalls
19 recalls in our records from 2019 to 2026: 19 FDA medical devices.
Recalls with full detail pages
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Avanos Medical, Inc. medical device recall: Brand Name: Ballard Product Name: Closed Suction Catheters…
Lack of sterility assurance for closed suction catheter systems
Earlier and other recalls
These link to the official agency notice.
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Avanos Medical, Inc. medical device recall: Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog… Official notice ↗
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Avanos Medical, Inc. medical device recall: MIC-KEY* Gastric-Jejunal Feeding Tube Kit Official notice ↗
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
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Avanos Medical, Inc. medical device recall: NEOMED* Pharmacy Syringes - Nonsterile Official notice ↗
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
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Avanos Medical, Inc. medical device recall: MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC*… Official notice ↗
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
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Avanos Medical, Inc. medical device recall: AVANOS BALLARD Closed Suction System for Adults Official notice ↗
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…
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Avanos Medical, Inc. medical device recall: COOLIEF RF Generator is an 80-watt Radio-Frequency Official notice ↗
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
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Avanos Medical, Inc. medical device recall: AVNS ambIT System - PIB/PCA W 2.5in Cath Official notice ↗
Some of the ambIT kits were potentially distributed without an air in-line filter.
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Avanos Medical, Inc. medical device recall: Avanos Ballard Oral Care Swab Official notice ↗
Incorrect expiration date.
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Avanos Medical, Inc. medical device recall: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics Official notice ↗
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…
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Avanos Medical, Inc. medical device recall: Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2… Official notice ↗
Sterile extension sets were distributed without an expiration date
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Avanos Medical, Inc. medical device recall: Avanos Cortrak 2 Enteral Access System Official notice ↗
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per…
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Avanos Medical, Inc. medical device recall: BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette… Official notice ↗
Product was distributed with incorrect expiration date.
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Avanos Medical, Inc. medical device recall: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL Official notice ↗
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
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Avanos Medical, Inc. medical device recall: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector Official notice ↗
Detachment of the Male AIV Adaptor from the Y-Connector.
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Avanos Medical, Inc. medical device recall: AVANOS MIC-KEY SF Gastrostomy Feeding Tube Official notice ↗
Devices had cracked or detached from the feeding tube body
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Avanos Medical, Inc. medical device recall: CORFLO Percutaneous Endoscopic Gastrostomy Official notice ↗
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
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Avanos Medical, Inc. medical device recall: Haylard Closed Suction System for Neonates/Pediatrics Official notice ↗
Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked.…
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Avanos Medical, Inc. medical device recall: CORFLO* Percutaneous Endoscopic Gastrostomy Official notice ↗
The connector piece to the PEG tube does not pass over the guidewire.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.