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Avanos Medical, Inc.

Avanos Medical, Inc. Recalls

All product recalls associated with Avanos Medical, Inc..

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 181–200 of 970 recalls

SMMT ambIT Kit (Avanos) – Missing Filter (2023)

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

SMMT ambIT Reusable Program (Avanos Medical) - Air Filter Issue (2023)

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

AVNS ambIT System (Avanos Medical) - Air Filter Issue (2023)

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

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VITROS HbA1c Reagent Kit (Ortho-Clinical) - Result Inaccuracy (2023)

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

FDAApr 17, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Calibrator Kit (Ortho-Clinical) - Calibration Problem (2023)

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

FDAApr 14, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Atellica CH Toxicology Calibrator (Siemens) – Calibration Reassignment (2023)

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

FDAApr 5, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry ToxAmmonia Calibrator (Siemens) – Calibration Reassignment (2023)

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

FDAApr 5, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Immundiagnostik IDK Lactoferrin ELISA (IMMUNDIAGNOSTIK) – no 510k (2023)

Marketed without a 510k

FDAMar 27, 2023Nationwide• IMMUNDIAGNOSTIK, Inc

STA Compact Analyzer (Diagnostica Stago) – coagulation time issue (2023)

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

STA Compact Max Analyzer (Diagnostica Stago) – coagulation time issue (2023)

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

STA R Max Instrument (Diagnostica Stago) – coagulation time issue (2023)

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Atellica IM Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS XT 7600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Anti-SARSCoV-2 Antibody Calibrators (Ortho-Clinical) – Calibration Levels (2023)

Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

FDAMar 9, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

FilmArray GI Panel (BioFire) – False Negative Results (2023)

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

FDAMar 8, 2023Nationwide• BioFire Diagnostics, LLC

Tempus Pro Patient Monitor (Remote Diagnostic) - Safety Issues (2023)

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

FDAFeb 23, 2023Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Avanos Oral Care Swab (Avanos) – Expiration Date Error (2023)

Incorrect expiration date.

FDAFeb 3, 2023Nationwide• Avanos Medical, Inc.

Ballard Access Suction System (Avanos) – Circuit Leak Risk (2023)

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.

FDAFeb 3, 2023Nationwide• Avanos Medical, Inc.