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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 161–180 of 1,000 recalls

Class IIOngoing

Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS

Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.

August 14, 2026 · DeviceView details →
Class IIOngoing

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 gloves

American Nitrile Operations Llc

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.

August 14, 2026 · DeviceView details →
Class IIOngoing

Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS

Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.

August 14, 2026 · DeviceView details →
Class IIOngoing

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 examination gloves

American Nitrile Operations Llc

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.

August 14, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove

American Nitrile Operations Llc

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.

August 14, 2026 · DeviceView details →
Class IIOngoing

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;

INTERVASCULAR, SAS

Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

August 12, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

CooperVision, Inc.

A small number of lenses within the affected lot are of the incorrect power.

August 12, 2026 · DeviceView details →
Class IIOngoing

GM Helix Implant, REF: 109.984;

Straumann USA LLC

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

August 12, 2026 · DeviceView details →
Class IIOngoing

HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.

Karl Storz Endoscopy

Due to incorrect inside packaging label for eyepiece.

August 12, 2026 · DeviceView details →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT 530 with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

August 11, 2026 · DeviceView details →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT 550 with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT 780 with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT ATLAS with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

August 11, 2026 · DeviceView details →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT ATLAS Astound with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software

Shanghai United Imaging Healthcare Co., Ltd.

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.

August 11, 2026 · DeviceView details →
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