Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · last month
GE Medical Systems Information Technologies Inc Portrait Core Services Software recall: Software issue may result in a loss of patient monitoring at the Hub
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory…
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Class II · last month
American Contract System Convenience Kit, D & C PACK, Model/ recall: The Convenience Kits contain Medline's Red Rubber Intermittent Catheters
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries…
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Class II · last month
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
AVID Medical, Inc. Brand Name: Halyard Product Name: Davinci Trucustom Bundle recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
Medline convenience kits labeled as: LTP CDS-LF recall: Kits contain a potentially contaminated component which were recalled
Kits contain a potentially contaminated component which were recalled by the manufacturer
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Class II · last month
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
Medline Hudson RCI, Dbd-Circuit,Vent,Inspiratory,Heated,NEO recall: Neonatal and infant heated wire breathing circuits may experience sporadic
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit…
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Class II · last month
Medline medical convenience kits, labeled as: 1) Sinus Pack-Lf recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to…
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Class II · last month
Canon Medical System, USA, INC. Alphenix Models Infx-8000C Infx-8000F Infx-8000V recall: Due to the fixing screws of ceiling movement gear in ceiling suspended arm
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
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Class II · last month
Merge Pacs and Merge OrthoPacs, medical imaging diagnostic workstation recall: Software issue may cause measurements to be displayed inaccurately
Software issue may cause measurements to be displayed inaccurately.
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Class II · last month
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine recall: Fresenius Medical Care Renal Therapies Group
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the…
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Class II · last month
Olympus Corporation of the Americas Powerseal 5 MM 23 CM , Curved Jaw Sealer & Divider recall: Potential labeling deficiency in which an outer shelf box is incorrectly
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
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Class II · last month
Medline convenience kits labeled as: 1) C-Section recall: Kits contain a potentially contaminated component which were recalled
Kits contain a potentially contaminated component which were recalled by the manufacturer
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Class II · last month
IMRIS Imaging Inc ORT300, operating room table, ORT300 Modular Table Main Unit Assy recall: The linear actuator and rotational lock mechanism components may experience
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between…
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Class II · last month
Medline breathing circuits labeled as: 1) Hudson RCI, Circuit, HTD recall: Neonatal and infant heated wire breathing circuits may experience sporadic
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit…
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Class II · last month
IMRIS Imaging Inc ORT200, operating room table, including the ORT200 Covered Table recall: The linear actuator and rotational lock mechanism components may experience
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between…
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Class II · last month
Medline convenience kits labeled as: 1) Major Procedure recall: Kits contain a potentially contaminated component which were recalled
Kits contain a potentially contaminated component which were recalled by the manufacturer
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Class II · last month
Medline convenience kits labeled as: 1) CMH Litho Minor Pack-Lf recall: Kits contain a potentially contaminated component which were recalled
Kits contain a potentially contaminated component which were recalled by the manufacturer
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Class II · last month
Medline convenience kits labeled as: 1) Lami Fusion recall: Kits contain a potentially contaminated component which were recalled
Kits contain a potentially contaminated component which were recalled by the manufacturer
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Class II · 2 months ago
SDI Limited Dentsply Sirona Capsule Mixer recall: Potential for electrical discharge from unit when unplugged
Potential for electrical discharge from unit when unplugged.
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Class II · 2 months ago
Maquet Critical Care AB Getinge Y Sensor Module, Servo-U, Servo-N recall: The module did not undergo electrical safety tests and functional tests
The module did not undergo electrical safety tests and functional tests during production.
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Class II · 2 months ago
Arrowhead DE LLC Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525 recall: Implant did not undergo required gamma radiation dose audit. A potential
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
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Class II · 2 months ago
Tobii Dynavox Llc TD Navio Maxi Speech Generating Device Model/ recall: Under certain conditions, the battery mounting tabs may become damaged
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading…
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Class II · 2 months ago
Beckman Coulter DxC 500i Clinical Analyzer Modules using software recall: a software defect in which the Parameter Package (PP) import logic overwrites
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously…