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
Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG recall: hCG rapid tests may detect low levels of hCG below the stated assay
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
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Class II · 18 days ago
Philips North America SmartPath to 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
Philips North America MR 5300 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 24" 1 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
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
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: MPR Product Name:Disposable Tourniquet Cuff 20" Dual 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
Bard Peripheral Vascular Inc EnCor EnCompass recall: Breast biopsy and tissue removal system may experience the following errors
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code…
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Class II · 18 days ago
ASP Global, LLC. Brand Name: MPR Product Name:Single USE Tourniquet Cuff 34" 1 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
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: MPR Product Name:Disposable Tourniquet Cuff 20" Dual 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
Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology REF recall: Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
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Class II · 18 days ago
Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall: There are identified discrepancies between the sterilization parameters
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in…
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Class II · 18 days ago
Percussionaire Corporation Impulsator, Product Number: S00010, Phasitron 5 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
ASP Global, LLC. Brand Name: MPR Product Name:Single USE Tourniquet Cuff 12" 1 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
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
Illumina, Inc. NovaSeq 6000Dx including Dragen Server recall: Retrospectively reported correction for an instrument intended for targeted
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro…
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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
Percussionaire Corporation In-Line Valve, Product Number: P5-TEE 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
ASP Global, LLC. Brand Name: MPR Product Name:Single USE Tourniquet Cuff 18" 1 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
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: MPR Product Name:Single USE Tourniquet Cuff 26" Dual 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 Upgrade dStream 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…