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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 241–260 of 1,000 recalls

Class IOngoing

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

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 IOngoing

Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

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 IOngoing

Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

August 11, 2026 · DeviceView details →
Class IOngoing

Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

August 11, 2026 · DeviceView details →
Class IOngoing

Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

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 IOngoing

Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number: DYNDH1245; 7) DYNDH1362, Catalog Number: DYNDH1362

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

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 →
Class IIOngoing

Computed Tomography X-ray System, Model: uCT 760 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 IOngoing

INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.

CooperSurgical, Inc.

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI 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 IOngoing

Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F

Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

August 11, 2026 · DeviceView details →
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