Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 8 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 8 months ago
Raz-AT Mobile Shower Commode Chair recall: Due to a modification by a vendor and may be reinstalled without properly
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in…
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Class II · 8 months ago
Waldemar Link GmbH & Co. KG Endo-Model SL Connection Component incl. PE-Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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Class II · 8 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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Class II · 8 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 8 months ago
International Life Sciences Artelon FlexBand Dynamic Matrix Ref: 31057 recall: Augmentation devices failed bacterial endotoxin testing
Augmentation devices failed bacterial endotoxin testing.
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Class II · 8 months ago
Beckman Coulter Mishima K.K. Chemistry Analyzer AU5800, REF: B96697, B96698 recall: A delay in results may occur. When clinical chemistry analyzer calibration
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open…
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Class II · 8 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class III · 8 months ago
Penner Pacific Bathing Spa, Model Numbers 360020-1P recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
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Class II · 8 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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Elevated risk · 8 months ago
Omnipod Alternate controller enabled insulin infusion pump recall: Pods may have a small tear in the internal tubing that delivers insulin
Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as…
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Class II · 8 months ago
Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System recall: Ongoing investigations identified additional instances of the device
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer…
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Class II · 8 months ago
Advanced Bionics, LLC Brand Name: HiResolution Bionic Ear System Product Name: Sky CI recall: Behind-the-ear sound processer packaging label is different then included
Behind-the-ear sound processer packaging label is different then included product.
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Class II · 8 months ago
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator recall: Mis-wired component-the improperly wired component can result in additional
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit…
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Class II · 8 months ago
Vascutek, Ltd. Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE recall: Gelatin sealed woven polyester prostheses devices
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life…
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Class II · 8 months ago
Diagnostica Stago, Inc. Brand Name: STA Liatest Free Protein S Product Name: STA recall: The potential of out-of-range results and an underestimation of the free
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects…
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Class II · 8 months ago
Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System recall: Ongoing investigations identified additional instances of the device
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer…
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Class II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged Infusion recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
Datascope Corp. CS100 Iabp. Software Version CS100 Iabp Q.01 recall: The firm has identified that the battery runtime and cycle specifications
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Class II · 8 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin . Material Number recall: Falsely depressed UAlb patient results may occur. Affected samples with any
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL…
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Class II · 8 months ago
Datascope Corp. CS300 Iabp. Software Version CS300 Iabp C.01 recall: The firm has identified that the battery runtime and cycle specifications
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Class II · 8 months ago
GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client recall: Under certain workflows, patient information shown in the viewer
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint…
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Class II · 8 months ago
Roche Diagnostics Operations, Inc. cobas pro integrated solutions with cobas c 503 recall: Software defect, which allows the system to accept erroneous
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is…