Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with Twister Blood recall: Heightened probability of blood leak from the connection between the Arterial
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may…
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Diagnostica Stago, Inc. STA Staclot Protein S, Model/ recall: A positive drift in QC values within the reagent's stated 4-hour onboard
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
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Class II · last month
AVID Medical, Inc. Halyard medical convenience kits labeled as: 1) A-P PACK - 205936 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 · last month
Medline Convenience Kits: 1) Blood Culture Tray Pediatric recall: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to…
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Class II · last month
American Contract System 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
GE Medical Systems Information Technologies Inc Portrait Core Services Software V1.1 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
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
Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm 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 convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U 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-W Protein Test for Robotic Arms 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
Medline convenience kits labeled as: Major Head AND Neck PPS 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
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.