Latest recalls — page 178
Older notices, newest first.
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Class II · 9 months ago
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recall: There may be voids located in the seal of Tyvek pouches associated
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has…
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Class II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. Menopause Test Cassette recall: Test strips and other tests including for near-patient testing
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S…
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Class II · 9 months ago
Intuitive Surgical, Inc. Brand Name: Da Vinci Product Name: da Vinci X recall: Due to a software implementation error that allowed instruments arms failing
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was…
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Class II · 9 months ago
Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Immunoreaction recall: Customers may experience inaccurate test results by observing a higher
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low…
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Class II · 9 months ago
Etac A/S Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog recall: A customer experienced that during assembly and load testing of the device
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Wilson-Cook Medical Inc. Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 recall: Nasal feeding tube packaged without the nasal transfer tube component
Nasal feeding tube packaged without the nasal transfer tube component.
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Class II · 9 months ago
Encore Medical, LP Empowr recall: 942-01-40G acetabular system package was found to contain 942-01-36H
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices…
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Class II · 9 months ago
Vortex Surgical Inc. Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 recall: There may be voids located in the seal of Tyvek pouches associated
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has…
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Class II · 9 months ago
Siemens Medical Solutions USA, Inc Naeotom Alpha.Prime Software applications recall: To remove the software applications from certain CT systems
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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Class II · 9 months ago
Etac A/S Brand Name: Molift Product Name: Molift 2-point sling bars recall: A customer experienced that during assembly and load testing of the device
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation…
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Class II · 9 months ago
Vortex Surgical Inc. Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens recall: There may be voids located in the seal of Tyvek pouches associated
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has…
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Class II · 9 months ago
Maquet Cardiopulmonary Gmbh Bubble Sensor for 3/8" x 3/32" tubing recall: Internal investigations have identified an issue with the durability
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor…
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Class II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. LH One Step Ovulation Test Device recall: Test strips and other tests including for near-patient testing
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S…
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Class I · 9 months ago
Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class I · 9 months ago
Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use Sphincterotome V Model/ recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Fujirebio Diagnostics, Inc. Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma recall: Customers may experience inaccurate test results by observing a higher
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low…
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Class II · 9 months ago
Vortex Disposable Forceps and Cannula 1. 23GA Actu8 Forceps Adaptive recall: There may be voids located in the seal of Tyvek pouches associated
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has…
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Class II · 9 months ago
Beckman Coulter, Inc. CellMek SPS recall: Sample preparation system designed to automate staining, lysing
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or…
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Class II · 9 months ago
Vantive Us Healthcare LLC Prismaflex HF1000 SET, Product Code 107142 recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.