Latest recalls — page 253
Older notices, newest first.
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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.
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Class II · 12 months ago
Daye Initiation 36 Coated Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp 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 Chemo Lock Universal Vented Vial Spike REF: CL-70-10 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 Vented Vial Spike, 20mm 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 Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 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 ChemosafeLock Connecter REF: KL-FNU3 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
Endomagnetics Ltd Magseed Pro 12 cm soft tissue marker recall: Potential for contamination with cotton fibers
Potential for contamination with cotton fibers.
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Class II · 12 months ago
CareFusion 303, Inc. BD Pyxis Pro MedStation Main, REF: 1155-00 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
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices recall: Due to incomplete seals in the pouch which provide the sterile barrier
Due to incomplete seals in the pouch which provide the sterile barrier.