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TradepilotUSA Recalls

device — TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · device

Percussionaire Corporation — Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — In-Line Valve, Product Number: P5-TEE

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instructi

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Percussionaire Corporation — Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…

Sandpoint, ID, US · Updated 9/28/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

American Nitrile Operations Llc — Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examina

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.

Grove City, OH, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Cardinal Health 200, LLC — Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Shanghai United Imaging Healthcare Co., Ltd. — Computed Tomography X-ray System, Model: uCT 550 with software

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Shanghai, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America — Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7.

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the …

Cambridge, MA, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America — Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the …

Cambridge, MA, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America — Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the …

Cambridge, MA, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America — SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the …

Cambridge, MA, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Bard Peripheral Vascular Inc — EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software

Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or…

Tempe, AZ, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America — MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the …

Cambridge, MA, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Cardinal Health 200, LLC — Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

American Nitrile Operations Llc — Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination g

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.

Grove City, OH, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference
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