Recalls affecting Washington
Notices that name Washington in their distribution area, plus every nationwide recall — nationwide recalls reach Washington too.
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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…
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Class II · 7 months ago
I.T.S. GmbH I.T.S. DUL System and UOL 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 OMNI III TEE 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 Mini Multi TEE 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 Brand Name: Humeral Head Plate with Angular Stability 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
Merit Medical Systems, Inc. DuraMax Chronic Hemodialysis Catheter recall: 16F dual-valved splittable sheath introducer due to a design defect
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies…
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Class II · 7 months ago
I.T.S. GmbH Claviculaplate 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 II · 7 months ago
Brand Name: Olympus Everest Bipolar 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
AMO Puerto Rico Manufacturing, Inc. Brand Name: Tecnis Eyhance IOL with Tecnis recall: Due to identifying a limited quantity of intraocular lenses that may have
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as…
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Class II · 7 months ago
I.T.S. GmbH I.T.S. Fibula Plate PROlock with Angular Stability with the below 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…