Applied Medical Technology Inc Recalls

All product recalls associated with Applied Medical Technology Inc.

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Recall Summary

Total Recalls

185

Past Year

4

Class I (Serious)

0

Most Recent

Oct 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 1–20 of 185 recalls

NutraGlide Nasal Feeding Tube (Applied Medical) – occlusion risk (2025)

The nasal feeding tube may be occluded

High

FDAOct 6, 2025Nationwide• Applied Medical Technology Inc

NutraGlide Nasal Feeding Tube (Applied Medical) – Tip Detachment Risk (2025)

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

High

FDAAug 12, 2025MA, RI• Applied Medical Technology Inc

MUSE 5 Systems (GE Medical) – Network Credential Risk (2025)

The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

High

FDAApr 25, 2025

Nationwide

• GE Medical Systems Information Technologies Inc

MEDITECH Expanse Software (Medical Information Technology) – data removal (2025)

Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

Low

FDAFeb 5, 2025Nationwide• Medical Information Technology, Inc.

AMT Mini Enteral Extension Set (Applied Medical) – Connector Mismatch (2024)

The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.

High

FDANov 26, 2024CA, CT, FL +15 more• Applied Medical Technology Inc

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

FDAJul 26, 2024Nationwide• Carbon Medical Technologies, Inc.

AMT Initial Placement Dilator (Applied Medical) – Guidewire Mislabeling (2024)

Devices were labelled with the incorrect guidewire labelling.

FDAMay 14, 2024Nationwide• Applied Medical Technology Inc

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

FDAApr 22, 2024Nationwide• GE Medical Systems Information Technologies Inc

CRITIKON ONE-CUF Blood Pressure Cuffs (GE Healthcare) – Inaccurate Measurements (2024)

Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

FDAApr 9, 2024Nationwide• GE Medical Systems Information Technologies Inc

Infinity Resection Adjustment Block (Wright Medical) – Manufacturing Defect (2024)

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

FDAMar 6, 2024NE, TX• Wright Medical Technology, Inc.

Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.

FDAAug 8, 2023CA, CO, FL +14 more• GE Medical Systems Information Technologies Inc

Stryker Infinity Alignment Frame (Wright Medical) – Pin Sleeve Hole Defect (2023)

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

FDAJun 13, 2023Nationwide• Wright Medical Technology, Inc.

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

OMTMO One Step Ovulation (LH) Test Strips REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Lem Fertility LH Ovulation Test (Strip) REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

DiagnosUS Ovulation Predictor Midstream REF 200-17 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

To Life hCG Pregnancy Urine Test Strips Format REF Cat No... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

PrestiBio Rapid Detection Pregnancy Test Midstream REF 10... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Stay Informed

Applied Medical Technology Inc Recalls

Recall Summary

NutraGlide Nasal Feeding Tube (Applied Medical) – occlusion risk (2025)

NutraGlide Nasal Feeding Tube (Applied Medical) – Tip Detachment Risk (2025)

MUSE 5 Systems (GE Medical) – Network Credential Risk (2025)

MEDITECH Expanse Software (Medical Information Technology) – data removal (2025)

AMT Mini Enteral Extension Set (Applied Medical) – Connector Mismatch (2024)

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

AMT Initial Placement Dilator (Applied Medical) – Guidewire Mislabeling (2024)

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

CRITIKON ONE-CUF Blood Pressure Cuffs (GE Healthcare) – Inaccurate Measurements (2024)

Infinity Resection Adjustment Block (Wright Medical) – Manufacturing Defect (2024)

Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

Stryker Infinity Alignment Frame (Wright Medical) – Pin Sleeve Hole Defect (2023)

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150... (Universal Meditech Inc.) – universal meditech inc (2023)

OMTMO One Step Ovulation (LH) Test Strips REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

Lem Fertility LH Ovulation Test (Strip) REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips (Universal Meditech Inc.) – universal meditech inc (2023)

DiagnosUS Ovulation Predictor Midstream REF 200-17 (Universal Meditech Inc.) – universal meditech inc (2023)

To Life hCG Pregnancy Urine Test Strips Format REF Cat No... (Universal Meditech Inc.) – universal meditech inc (2023)

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 (Universal Meditech Inc.) – universal meditech inc (2023)

PrestiBio Rapid Detection Pregnancy Test Midstream REF 10... (Universal Meditech Inc.) – universal meditech inc (2023)