Latest recalls — page 179
Older notices, newest first.
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Class II · 9 months ago
Vortex Surgical Inc. 25GA Subretinal Injection Cannula VS0220.25 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. Vivoo Sodium Test 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
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
Changchun Wancheng Bio-Electron Co., Ltd. Vivoo pH Test 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
Olympus Corporation of the Americas Brand 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 II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. The Girlfriend Doctor Dr. Anna Cabeca 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
Vortex Surgical Inc. Tecfen Retractable Membrane Polisher, QTPR1267-23 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 Software applications: syngo.CT 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
Tornier Perform Reversed Perip Screw 5.0MMX18MM NON Sterile recall: A specific lot of screws is incorrectly labeled. Screws are labeled
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during…
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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
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 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
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 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. S. Typhi/Para Typhi A Antigen 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
Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 recall: A software timing and processor communication issue in MiniMed" 780G software
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting…
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Class II · 9 months ago
Vortex Surgical Inc. Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser 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
Fujirebio Diagnostics, Inc. Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/ 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
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
Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau217/B-Amyloid 1-42 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
Olympus Corporation of the Americas Brand Name: Single Use Electrosurgical Knife recall: A deterioration of the cutting knife, including overheating and burning
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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Class II · 9 months ago
Vantive Us Healthcare LLC Prismaflex ST150 SET US, Product Code 107640US 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.
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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 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
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus recall: A deterioration of the cutting knife, including overheating and burning
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.