Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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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.
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Class I · 2 months ago
Boston Scientific Enroute Transcarotid Neuroprotection System Plus 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 III · 2 months ago
Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev recall: Device was recalled due to an elevated oxygen level in excess
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material…
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Class II · 2 months ago
Siemens Healthineers Immulite 2000 Systems SYP recall: Syphilis Screen assay may contain a negative patient bias resulting in low
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
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Class II · 2 months ago
ConvaTec, Inc Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703 recall: Urostomy Pouches may leak from cap during use
Urostomy Pouches may leak from cap during use.
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Class II · 2 months ago
Philips North America Llc Cardiac Workstation 7000. Product Number: 860441 recall: Device will intermittently provide inaccurate data related to native heart
Device will intermittently provide inaccurate data related to native heart rate.
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Class I · 2 months ago
BMC/Reacthealth Luna G3 Apap REF LG 3600 recall: Retroactive reporting for 2024 rework conducted at the 3B/React Health
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
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Class II · 2 months ago
Covidien, LLC EndoFlip System that includes: Endoflip 1 System EF-100 05391530810050 recall: The system's 24-hour usage limit results in catheters incorrectly flagged
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
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Class III · 2 months ago
Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Small Right Rev recall: Device was recalled due to an elevated oxygen level in excess
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material…
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Class II · 2 months ago
Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation recall: Device may fail to deploy the cinch implant and/or fail to cut the suture
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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Class II · 2 months ago
Siemens Healthineers Immulite 2000 Systems SYP recall: Syphilis Screen assay may contain a negative patient bias resulting in low
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
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Class II · 2 months ago
Philips North America Llc Cardiac Workstation 5000. Product Number: 860439 recall: Device will intermittently provide inaccurate data related to native heart
Device will intermittently provide inaccurate data related to native heart rate.
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Class II · 2 months ago
Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW 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
American Contract Systems medical procedure kits and trays labeled recall: The recall notice was initiated due to a Medicom Urgent Medical Device
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…
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Class II · 2 months ago
Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler recall: Software issue that can cause an increase in spontaneous software closures
Software issue that can cause an increase in spontaneous software closures.