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
Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product recall: Due to display cables used for monitors were not in compliance
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose…
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Class II · 1+ years ago
American Contract Systems Inc. Medical convenience kits recall: Identified products were re-gassed (sterilized more than once) after
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection…
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Class II · 1+ years ago
American Contract Systems Inc. Medical convenience kits Udpg88W Picc G-Tube recall: Identified products were re-gassed (sterilized more than once) after
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection…
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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 Continu-Flo Solution Set, Non-Vented recall: IV sets may leak
IV sets may leak.
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Class I · 1+ years ago
Evis Exera b Bronchovideoscope Olympus Bf-Xt190 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
Insulet Corporation recall: The failure occurs if a user on the Omnipod 5 iOS application selects
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the…
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Class I · 1+ years ago
Evis Exera III Bronchovideoscope Olympus BF-Q190 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 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 II · 1+ years ago
American Contract Systems Inc. Basic Biopsy Tray recall: Identified products were re-gassed (sterilized more than once) after
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection…
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Class II · 1+ years ago
GE Medical Systems, LLC LOGIQ P9 R4.5 ultrasound system with system software version recall: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could…
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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
Iantrek Inc. Cyclopen Microinterventional Cyclodialysis System recall: Potential for compromised integrity of the sterile packaging
Potential for compromised integrity of the sterile packaging.
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Class I · 1+ years ago
Bronchovideoscope Olympus BF Type 1T150 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 II · 1+ years ago
Fisher & Paykel Healthcare, Ltd. Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US recall: When unintentionally disconnected from power source
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound…
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Class I · 1+ years ago
Cook Medical Incorporated Zenith Alpha 2 Thoracic Endovascular Graft recall: Affected devices may contain PTFE coating scrapings. Scrapings
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular…
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Class I · 1+ years ago
Bronchovideoscope Olympus BF-H1100 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 II · 1+ years ago
American Contract Systems Inc. Medical convenience kits recall: Identified products were re-gassed (sterilized more than once) after
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection…
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Class II · 1+ years ago
Iantrek Inc. C-Rex UNO Microinterventional Goniotomy Instrument recall: Potential for compromised integrity of the sterile packaging
Potential for compromised integrity of the sterile packaging.
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Class II · 1+ years ago
Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product recall: Due to display cables used for monitors were not in compliance
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose…
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Class I · 1+ years ago
Boston Scientific Corporation Accolade DR EL MRI 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
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…