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
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 recall: The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
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Class II · 12 months ago
Medtronic Perfusion Systems Affinity NT Oxygenator recall: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
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Class II · 12 months ago
Integra LifeSciences Corp. TruDi¿ Navigation System - Multi Instrument Adapter recall: It was determined that when the navigation system is configured with specific
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the…
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Class II · 12 months ago
Beckman Coulter Inc. Synchron Systems Direct LDL Cholesterol Reagent, REF: 969706 recall: Beckman Coulter has identified that there is an increased probability
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166…
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Class II · 12 months ago
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456 recall: An internal investigation has determined that due to defective sub-components
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may…
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Class I · 12 months ago
Tandem Mobi recall: Insulin pump includes a vibration motor that gives tactile feedback for any
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor…
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Class I · 12 months ago
Integra LifeSciences Corp. Codman Disposable Perforator 9mm. Cranial Perforator recall: Expansion of recall of size 14 mm Codman Disposable Perforators
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an…
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Class II · 12 months ago
Elekta, Inc. Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage recall: Due to increased risk that paint flakes from the engravings may separate
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may…
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Class II · 12 months ago
B-K Medical A/S bk3500 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Spacelabs Healthcare, Ltd. Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/ recall: Due to two distinct issues: 1. During patient admission
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems…
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Class II · 12 months ago
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P recall: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be…
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Class II · 12 months ago
B-K Medical A/S bk3000 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814 recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head Model/ recall: Potential packaging issue that could compromise the sterile barrier. Defect
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk…
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Class II · 12 months ago
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
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Class II · 12 months ago
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS recall: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be…
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Class II · 12 months ago
B-K Medical A/S UUltrasound System 2300, bkActiv w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260 recall: An internal investigation has determined that due to defective sub-components
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S bk5000 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…