Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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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
Beckman Coulter, Inc. Coulter DxH Diluent, REF 628017 Coulter DxH ECO Diluent REF recall: Due to specific lots of diluents contributing to elevated platelet Daily
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
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Class II · 9 months ago
Vortex Surgical Inc. Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2 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 I · 9 months ago
True Metrix Blood Glucose Monitoring Systems recall: As currently written, the Owner’s Booklets/System Instructions for Use fails
As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they…
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Class II · 9 months ago
CareFusion 303, Inc. BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 recall: Due to a number of modules flashed with a date and time associated
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: Circumcision recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta recall: Due to a manufacturing issue and electrical grounding of systems
Due to a manufacturing issue and electrical grounding of systems.
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Class II · 9 months ago
NIPRO Technical Services, Inc. Conductivity Standard Solution Catalog/Model Numbers recall: due to a defect associated with the conductivity values of the solution used
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect…
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Class II · 9 months ago
Canon Medical System, USA, INC. Alphenix INFX-8000C recall: It has been discovered that there is a possibility that the fixing screws
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Middle EAR recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Gold Star Distribution Inc Bandages and first aid kits: First AID KIT 24/42PC recall: Potential exposure of rodents and rodent activity in the distribution center
Potential exposure of rodents and rodent activity in the distribution center.
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) MEM recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class I · 9 months ago
SunMed Holdings, LLC Brand Name: Broselow Product Name: Broselow Pediatric Emergency recall: Product contains potentially harmful dosing errors for Vecuronium
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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Class II · 9 months ago
Philips North America Ingenia 1.5T. Product Code : 781341 recall: The potential for stiffness value errors when viewing exported MR
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Pacer / Cath recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Aju Pharm Co., Ltd. Genesis Screw-In Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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Class II · 9 months ago
Canon Medical System, USA, INC. Alphenix INFX-8000V recall: It has been discovered that there is a possibility that the fixing screws
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of…
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Class II · 9 months ago
Gold Star Distribution Inc Pregnancy Test 24CT recall: Potential exposure of rodents and rodent activity in the distribution center
Potential exposure of rodents and rodent activity in the distribution center.
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Class II · 9 months ago
Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System: Luminos recall: Ortho images acquired with preset automatic horizontal flip are not flipped
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image…
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Class II · 9 months ago
Canon Medical System, USA, INC. Alphenix INFX-8000H recall: It has been discovered that there is a possibility that the fixing screws
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of…
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Class I · 9 months ago
SunMed Holdings, LLC Brand Name: Broselow Product Name: Broselow" Filled Broselow recall: Product contains potentially harmful dosing errors for Vecuronium
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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Class II · 9 months ago
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/ recall: Incorrect expiration date
Incorrect expiration date
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Class II · 9 months ago
Gold Star Distribution Inc Condoms, labeled as: Trojan Magnum Condoms 6/DSP Black recall: Potential exposure of rodents and rodent activity in the distribution center
Potential exposure of rodents and rodent activity in the distribution center.
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Class II · 9 months ago
Aju Pharm Co., Ltd. Genesis Dual Thread Screw-In Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.