Avanos Medical, Inc.
19 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (19)
Registered facilities (3)
- AVENT S. de R.L. de C.V. FEI 3002806436 · MX
- Avent S. de R.L. de C.V. FEI 3007596547 · MX
- Avanos Medical, Inc. FEI 3011270181 · GA
Recalls & enforcement
20261 record
- Class IIOngoing2026-04-30Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
20251 record
- Class IOngoing2025-03-19Lack of sterility assurance for closed suction catheter systems
20243 records
- Class IIOngoing2024-05-31The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
- Class IIIOngoing2024-03-04The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Class IOngoing2024-01-16MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
20235 records
- Class IIOngoing2023-10-13Certain 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 IICompleted2023-08-01Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
- Class IITerminated2023-04-24Some of the ambIT kits were potentially distributed without an air in-line filter.
- Class ITerminated2023-02-03Potential 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.
- Class IITerminated2023-02-03Incorrect expiration date.
20222 records
- Class IITerminated2022-09-14Sterile extension sets were distributed without an expiration date
- Class ITerminated2022-03-21Product 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 institution protocol.
20212 records
- Class IITerminated2021-12-22The External Retention Bolster contained in the kit may be a larger diameter than the tube.
- Class IITerminated2021-11-22Product was distributed with incorrect expiration date.
20203 records
- Class IITerminated2020-10-16Detachment of the Male AIV Adaptor from the Y-Connector.
- Class IITerminated2020-07-29Devices had cracked or detached from the feeding tube body
- Class IITerminated2020-03-16The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
20192 records
- Class IITerminated2019-11-05Avanos 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. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form t…
- Class IITerminated2019-10-08The connector piece to the PEG tube does not pass over the guidewire.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Avanos Medical, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2022573-avanos-medical-inc/
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