Latest recalls — page 180
Older notices, newest first.
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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
Siemens Medical Solutions USA, Inc Somatom X.ceed 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
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. LotFancy Urinary Tract Infection Urine 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
Encore Medical, LP Empowr 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 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
Siemens Medical Solutions USA, Inc Naeotom Alpha.Pro 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
Vantive Us Healthcare LLC Prismaflex HF1000 SET, Product Code 107140 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
Vantive Us Healthcare LLC Prismaflex TPE2000 SET, Product Code 114093 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
Vortex Surgical 25GA Backflush, VS0270.25 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
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 I2 Injection Kit, VS0500 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
Olympus Corporation of the Americas Brand Name: CleverCut Product Name: Single Use 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 II · 9 months ago
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B recall: XXX
XXX
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Class II · 9 months ago
Vantive Us Healthcare LLC Prismaflex M150 SET, Product Code 109990 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 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
FUJIFILM Healthcare Americas Corporation FDR Visionary Suite recall: It was found that the contacts of the electromagnetic contactors used inside
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the…
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Class II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Protein 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
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA 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
Vantive Us Healthcare LLC Oxiris SET, Product Code 112016 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
Vantive Us Healthcare LLC Prismaflex ST100 SET US, Product Code 107636US 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.