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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 201–220 of 39,430 recalls

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 →
Class IIOngoing

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

Becton, Dickinson and Company

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

August 11, 2026 · DeviceView details →
Class IIOngoing

Positron Emission Tomography and Computed Tomography System, Model: uMI 780

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

Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;

AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.

Medline Industries, LP

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

August 10, 2026 · DeviceView details →
Class IIOngoing

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA

Merit Medical Systems, Inc.

Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.

August 10, 2026 · DeviceView details →
Class IIOngoing

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P

American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).

August 10, 2026 · DeviceView details →
Class IIOngoing

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

August 10, 2026 · DeviceView details →
Class IOngoing

Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

August 10, 2026 · DeviceView details →
Class IIOngoing

ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, Catalog Number: DYNJ54479C; 13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815; 14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C; 15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C; 16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C; 17) SPINAL PACK-LF, Catalog Number: DYNJ67543B; 18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A; 19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098; 20) SPINE, Catalog Number: DYNJ900269I; 21) PACK,CRANIOTOMY, Catalog Number: DYNJ906893C; 22) PACK,CRANIOTOMY, Catalog Number: DYNJ906893D; 23) PACK,CRANIOTOMY, Catalog Number: DYNJ906893F; 24) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192B; 25) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192C; 26) DR MOSHEL CRANI, Catalog Number: DYNJ907920C; 27) SPINE-LF, Catalog Number: DYNJ910956; 28) TOURO OR LAMINECTOMY PACK, Catalog Number: DYNJ912687

Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

August 10, 2026 · DeviceView details →
Class IIOngoing

CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
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