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
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.
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Class II · 12 months ago
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS 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
IMPRIS Imaging Inc IMRIS Operating Suite, InVision 3T Operating Suite recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 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 18 Coated Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 3 Month Regular Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye 9 Coated Super Tampons 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 Refill 18 Coated Regular and 18 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 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 Refill 3 Month All in One Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, Neuro III-SV iMRI System recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
Philips Medical Systems Model: Incisive CT for Brazil SKD 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
Alcon Precision1 One-Day Contact Lenses, -2.25D recall: Potential for a weak seal in some units resulting in compromise in sterility
Potential for a weak seal in some units resulting in compromise in sterility.
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Class II · 12 months ago
Olympus Bronchofiberscopes and bronchovideoscopes recall: Potential for endobronchial combustion
Potential for endobronchial combustion
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Class II · 1+ years ago
Sedecal Sa recall: Sedecal sent an email to its consignees to remind the users
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the…
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Class II · 1+ years ago
Cardinal Health 200, LLC Salem Sump PVC Tubes: Product Code/Product Name: 266122 recall: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for…