Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Open Heart CDS recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Centinel Spine, Inc. Prodisc C SK U.S. Implant Extra Large 5MM. Model: Pdsxl5 Total recall: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm…
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Class II · 6 months ago
Medline Convenience Kits: 1) Lithotomy Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
DFI Co., Ltd. One Step K in vitro diagnostic test REF: 81A4 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Medline Convenience Kits: 1) PPE KIT recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) WMC I D PACK-LF recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class I · 6 months ago
AVID Medical, Inc. Halyard Cardiac Cath Tray Shands JAX kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Plastic BIN recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Philips SmartPath to dStream for 1.5T with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 4 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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Class II · 6 months ago
Philips SmartPath to dStream for XR and 3.0T with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline and Centurion medical procedure kits recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Philips Ingenia Ambition X with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Philips Upgrade to MR 7700 with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Zimmer, Inc. Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing recall: Ten complaints have been received identifying issues at the time of use
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the…
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Class II · 6 months ago
Clinical Innovations, LLC Brand Name: Kiwi Omni Vacuum Delivery System Product Name recall: Due to complaints of device breakage at the traction force gauge to handle
Due to complaints of device breakage at the traction force gauge to handle joint.
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Class II · 6 months ago
Centurion medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Philips Ingenia Elition S with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Abbott Point Of Care Inc. i-STAT EG6+ cartridge recall: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number…
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Class II · 6 months ago
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 4 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…