Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 12 months ago
ICU Medical ChemoLock Port REF: CL2100 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class I · 12 months ago
Balt USA, LLC Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega recall: Due to an identified manufacturing defect involving coating material lifting
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
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Class II · 12 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Micro Capillary Blood Collection recall: All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when…
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Class II · 12 months ago
CareFusion 303, Inc. Various models of BD Pyxis MedFlex recall: Potential fluid ingress of anesthesia station or med station may result
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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Class II · 12 months ago
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System recall: Printer Support Module (PSM) may be subject to insufficient soldering
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected…
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Class II · 12 months ago
Brand Name: Aesculap Product Name: Reducing Converter 10/12MM TO 5MM recall: It was determined there is the potential of silicone fragments detaching
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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Class II · 12 months ago
SpineAR Surgical Navigation Advanced Platform Patient Engagement recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
ICU Medical 30" Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Endo Surgical Navigation Advanced Platform Patient Engagement recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Brand Name: Aesculap Product Name: Sealing Unit F/10/12MM Trocars recall: It was determined there is the potential of silicone fragments detaching
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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Class II · 12 months ago
Beckman Coulter, Inc. CellMek SPS Sample Preparation System recall: Automated pipetting, diluting and specimen processing workstations for flow
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead…
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Class II · 12 months ago
Philips Medical Systems Model: CT 5300 recall: Issue 1: The potential for unintentional continued gantry/couch movement
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2…
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Class II · 12 months ago
Surgical Planner, BrainSTORM, software version BST.9.3.0 recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
SuRgical Planner , software version SRP.7.12.0 recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye Initiation 3 Month Trial Tampon Box recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 30" Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Canon Medical System, USA, INC. Vantage Galan 3T. Cmsc Model: MRT-3020/U7 recall: Affected system contains components that do not meet the required distance
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for…
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Class II · 12 months ago
Daye 9 Coated Super and 9 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.