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
Medline Adult Anesthesia Set, REF DYNJ39985G recall: Specific items and lots of Medline Kits may contain Clearlink IV Sets
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
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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 II · 1+ years ago
Boston Scientific Corporation LGX Preconnect with Tenacio Pump with InhibiZone recall: The potential for devices to experience inflation and/or deflation
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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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
ConvaTec, Inc DuoDerm" Extra Thin dressings are highly flexible recall: Wound dressing may have foreign matter on the product
Wound dressing may have foreign matter on the product.
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Class I · 1+ years ago
Evis Exera III Bronchovideoscope Olympus BF-1TH190 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 Accolade SR SL 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
OES Bronchofiberscope Olympus BF Type P60 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
GE Medical Systems, LLC LOGIQ P10 series with software version R4.5.7 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 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
Boston Scientific Corporation CX Preconnect with Tenacio Pump without InhibiZone recall: The potential for devices to experience inflation and/or deflation
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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Class II · 1+ years ago
Boston Scientific Corporation CXR Preconnect with Tenacio Pump with InhibiZone recall: The potential for devices to experience inflation and/or deflation
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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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 I · 1+ years ago
Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F recall: Abbott has become aware of a limited number of tip detachment events during
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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Class I · 1+ years ago
Evis Exera III Bronchovideoscope Olympus BF-P190 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 Accolade DR EL 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
Lutronic Corporation Xerf Effector 60. Electrosurgical unit recall: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
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Class II · 1+ years ago
BioPro Femoral Head Product ID/Description 14089 Head Femoral 28 SH LT recall: Potential packaging issue that could compromise the sterile barrier. Defect
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk…
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Class I · 1+ years ago
Boston Scientific Corporation Accolade DR SL 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. 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 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
BioPro Endo Head Product ID/Description 13006 Endo Modular Ceramic SH recall: Potential packaging issue that could compromise the sterile barrier. Defect
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk…