Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 7 months ago
Burlington Medical, Wrap Aprons recall: Potential for attenuation degradation over time, decreasing the lifespan
Potential for attenuation degradation over time, decreasing the lifespan.
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Class II · 7 months ago
Medtronic MiniMed, Inc. Paradigm REAL-Time Insulin Pump recall: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and…
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Class II · 7 months ago
Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 18G recall: There was an error in inspection and programming of the eTRAX needle sensor
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip…
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Class II · 7 months ago
Medtronic MiniMed, Inc. MiniMed 720G Insulin Pump recall: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and…
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Class II · 7 months ago
Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument recall: Due to increased in complaints regarding frayed or broken pitch cables
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
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Class II · 7 months ago
GE Healthcare LLC SIGNA Premier systems recall: Whole-Body MR scanners used to produce images of the inside of the human body
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with…
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Class II · 7 months ago
Medline Industries, LP Thoracic Robots, Dynj908777B recall: Kits contain recalled Olympus biopsy valves. Olympus is investigating
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the…
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Class I · 7 months ago
Philips Respironics Trilogy Evo, Software Version 1.05.15.00 recall: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume…
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Class II · 7 months ago
Medline Industries, LP Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 recall: Elevated endotoxin levels identified in affected lots. Issue may elicit
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation…
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Class II · 7 months ago
I.T.S. GmbH Pelvic Reconstruction System with the below descriptions recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class III · 7 months ago
Philips L12-5 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
Brand Name: Olympus Halo PKS Cutting Forceps recall: Olympus identified that the Cutting Forceps contain components
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective…
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Class II · 7 months ago
Beckman Coulter, Inc. MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 recall: Due to the likely presence of contamination in well(s)
Due to the likely presence of contamination in well(s).
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Class II · 7 months ago
I.T.S. GmbH Volar Radius Plate with Angular Stability with the following recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class I · 7 months ago
Erbe USA Inc Flexible Cryoprobe REF: 20402-410. For surgical use recall: Probes may rupture/burst during activation
Probes may rupture/burst during activation
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Class III · 7 months ago
Philips C9-4 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
Koven Technology, Inc. Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler recall: Product labeling includes a fetal indication for use that is not cleared
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
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Class II · 7 months ago
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS recall: Olympus identified that the Cutting Forceps contain components
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective…
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Class II · 7 months ago
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord recall: Olympus identified that the Cutting Forceps contain components
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective…
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Class II · 7 months ago
I.T.S. GmbH Pilonplate with Angular Stability, with the below descriptions recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class III · 7 months ago
Philips X7-2 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 7 months ago
Philips 3D6-2 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
I.T.S. GmbH FR.O.H. Calcaneus Repair System with the following description recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class II · 7 months ago
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw recall: A material mix-up had occurred during the manufacturing of Straumann¿ Custom
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP…