Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · last month
Philips Incisive CT with software V4.5&V5.0 recall: Potential of failing to trigger clinical scan during Bolus Tracking
Potential of failing to trigger clinical scan during Bolus Tracking.
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Class II · last month
Fujifilm Synapse Pacs software v7.4.310 recall: Software issue may cause the ruler measurement to be inaccurate
Software issue may cause the ruler measurement to be inaccurate.
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Class II · last month
American Contract System Convenience Kit, CV B PACK, Model/ recall: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries…
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Class II · last month
Medline medical convenience kits, labeled as: 1) Laminectomy Pack recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to…
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Class II · last month
Medline medical convenience kits, labeled as: 1) Craniotomy Pack recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to…
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Class II · last month
Medline convenience kits labeled as: 1) Open Heart Pack 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
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
Midmark IQecg Digital ECG, Model/ recall: A communication anomoly may result in incorrect electrocardiogram waveforms
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
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Class II · last month
Medline convenience kits labeled as: 1) GYN Robotic CDS 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
healthmark ProChek-II recall: Test manufactured with an expired ingredient which may present as either
Test manufactured with an expired ingredient which may present as either a false negative or positive.
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Class II · last month
Conmed Linvatec Genesys CrossFT recall: Suture anchor may contain incorrect patient implant card which may result
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
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Class II · last month
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
GE Medical Systems Information Technologies Inc FRU recall: Software issue may result in a loss of patient monitoring at the Hub
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory…
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Class II · last month
Medline convenience kits labeled as: 1) Femoral Pack 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
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
Medline breathing circuits labeled as: 1) Medline Hudson RCI 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
AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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Class II · last month
Henry Schein Inc. Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall: Specific lots were distributed in the US with incorrect packaging
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
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Class II · last month
Medline medical convenience kits, labeled as: 1) NEURO CDS recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to…
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Class II · last month
Midmark Digital ECG HD+12, HD+15, Model/ recall: A communication anomoly may result in incorrect electrocardiogram waveforms
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
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Class II · last month
Hollister Ulc Onli 17cm Hydrophilic Urethral Intermittent Catheter recall: Hollister has identified that select lots of the catheters identified
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect…
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Class II · last month
Medline medical convenience kit labeled as: Trach Tube KIT recall: Component labeling discrepancy
Component labeling discrepancy
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Class II · last month
Medline convenience kits labeled as: 1) Major GYN Pack 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
GE Medical Systems Information Technologies Inc Portrait Compute AND Core Services recall: Software issue may result in a loss of patient monitoring at the Hub
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory…