Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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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…
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Class II · 2 months ago
Gentherm Medical, LLC Innercool Coolblue Console, Model STx recall: Overheating of the 115V CPU board may cause the device to shut down
Overheating of the 115V CPU board may cause the device to shut down.
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Class II · 2 months ago
Fort Defiance Industries recall: The Automated Field Steam Sterilizer's water recovery system 120V Amphenol
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which…
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Class II · 2 months ago
Gentherm Medical, LLC Blanketrol III, Model 233 recall: Overheating of the 115V CPU board may cause the device to shut down
Overheating of the 115V CPU board may cause the device to shut down.
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Class I · 2 months ago
Boston Scientific Enroute Transcarotid Neuroprotection System recall: Potential for arterial sheath tip separation or partial tip separation during
Potential for arterial sheath tip separation or partial tip separation during use.
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Class II · 2 months ago
Beckman Coulter DxC 500 AU 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…
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Class I · 2 months ago
Bard Access Systems, Inc. BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK recall: After placement of intraosseous (IO) needle sets
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically…
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Class II · 2 months ago
Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712 recall: Loaner insulin pumps may have been cleaned with chemically incompatible
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress…
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Class II · 2 months ago
Spectral Instruments Inc Ami HTX recall: Momentary absence of On-Screen "X-Ray On" banner during run readiness check
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
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Class II · 2 months ago
Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782 recall: Loaner insulin pumps may have been cleaned with chemically incompatible
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress…
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Class II · 2 months ago
Spectral Instruments Inc Lago X recall: Momentary absence of On-Screen "X-Ray On" banner during run readiness check
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.