Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 18 days ago
American Contract Systems Inc Medical convenience kits containing BD CliniClean recall: Kits contain manufacturer-recalled perineal care (pericare) wipes within
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name: Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
Brand Name: ASP Global Product Name:Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name:Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name: Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
Spectrum Medical Srl Brand Name: Quantum PureFlow Product Name: Quantum PureFlow recall: Due to blood-to-glycol leak in the heat exchanger
Due to blood-to-glycol leak in the heat exchanger.
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Class II · 18 days ago
Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and Ahto recall: The kits contain tube sets with handpieces that may leak during use
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name: Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
Philips North America MR 7700 recall: When exporting diffusion tensor imaging (DTI) scans from a MR system using
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: MPR Product Name:Single USE Tourniquet Cuff 44" 2 Line recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV HC recall: Labeling updated warning not to use Intrapulmonary percussive ventilation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV…
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Class II · 18 days ago
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System recall: Positron emission tomography and computed tomography x-ray systems have
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS…
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Class II · 18 days ago
Merit Medical Systems, Inc. Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall: Microspheres used in embolization of tumors
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may…
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Class II · 18 days ago
Spectrum Medical Srl Brand Name: Quantum PureFlow Product Name: Quantum PureFlow recall: Due to blood-to-glycol leak in the heat exchanger
Due to blood-to-glycol leak in the heat exchanger.
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name:Disposable BB Tournquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name: Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 18 days ago
Philips North America Ingenia 3.0T and 3.0T CX recall: When exporting diffusion tensor imaging (DTI) scans from a MR system using
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
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Class I · 18 days ago
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall: Potential fire hazard involving the hand control pendant and associated
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: Expressaire Product Name: Disposable Tourniquet Cuff recall: Due to incorrect expiration date on product manufactured between September
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The…
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Class II · 25 days ago
Medline Convenience Kits: 1) Major Pack recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…
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Class II · 25 days ago
Medline Convenience Kits: 1) Peds Sinus Pack recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…
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Class II · 25 days ago
Philips North America Llc SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 25 days ago
Philips North America Llc Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 25 days ago
Medline Convenience Kits: 1) MFC Craniotomy Pack recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…