Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Continu-Flo Solution Set, Non-Vented recall: IV sets may leak
IV sets may leak.
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Evis Exera Bronchovideoscope Olympus BF Type XT160 recall: Additional IFU updates to provide further clarification on safe and effective
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Solution Set, Duo-Vent recall: IV sets may leak
IV sets may leak.
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Set recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class I · 1+ years ago
NOxBOXi Nitric Oxide Delivery System recall: The unexpected internal fault / system diagnostic error to result
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without…
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Class II · 1+ years ago
LeMaitre Vascular, Inc. Artegraft Collagen Vascular Graft. Model/Catalog/Part recall: Devices were distributed with incorrect label without CE and UKCA mark
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
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Class II · 1+ years ago
Applied Medical Technology Inc NutraGlide recall: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
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Class II · 1+ years ago
Applied Medical Technology Inc NutraGlide recall: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
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Class II · 1+ years ago
FUJIFILM Healthcare Americas Corporation FDR Visionary Suite recall: It was found that the shaft for mounting the X-ray tube unit on the support
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not…
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray with Perifix 17 recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
Fresenius Medical Care Holdings, Inc. Optiflux¿ High Flux E-beam Dialyzer Model recall: To provide further information to the user to ensure proper use
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a…
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
Beckman Coulter Inc. Synchron Systems Phosphorus Reagent REF: 467868 For In Vitro recall: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868)
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which…
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Class II · 1+ years ago
Applied Medical Technology Inc NutraGlide recall: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
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Class II · 1+ years ago
Inpeco S.A. FlexLab System. Potassium Test System. in vitro diagnostic recall: The FlexLab System Sample Integrity Module (SIM) includes function
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This…
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Class II · 1+ years ago
B Braun Medical Inc Design Options, Pain Management Tray. Product Code: Sesk. Product recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
B Braun Medical Inc Design Options, Perifix FX Epidural Anesthesia Tray. Product Code recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray with Perifix 17 recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
Inpeco S.A. FlexLab X System. Potassium Test System. in vitro diagnostic recall: The FlexLab X System Sample Integrity Module (SIM) includes function
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This…
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Class II · 1+ years ago
Corneat Vision, Ltd. EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix recall: Reviewed complaints have identified that conjunctival wound dehiscence
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.