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
Sedecal Sa MobileDiagnost wDR 2.2 recall: Sedecal sent an email to its consignees to remind the users
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the…
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Class II · 1+ years ago
Medline Industries, LP Excelsior Medical, 0.9% Sodium Chloride Injection recall: Medline has identified a limited quantity of saline IV flush syringes
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
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Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Solution Set, Non-Vented recall: IV sets may leak
IV sets may leak.
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Class II · 1+ years ago
Microvention Inc. Flow Re-Direction Endoluminal Devices: Fred 27 recall: Flow diverter may have a manufacturing issue related to the tantalum length
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be…
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Class I · 1+ years ago
Boston Scientific Corporation Accolade DR SL 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
Bronchovideoscope Olympus BF-Q170 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 Extension SET recall: IV sets may leak
IV sets may leak.
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Class I · 1+ years ago
Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF 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
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. 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
OES Bronchofiberscope Olympus BF Type MP60 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 Proponent 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
BioPro Femoral Head Product ID/Description 19023 Head Femoral Ceramic 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 II · 1+ years ago
Boston Scientific Corporation CX 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
Evis Exera II Bronchovideoscope Olympus BF Type Q180 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 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 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
Evis Exera II Bronchovideoscope Olympus BF Type 1TQ180 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 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
BioPro Endo Head Product Number/Description 10179 Endo MD 38 10180 Endo 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 II · 1+ years ago
Contego Medical LLC Neuroguard IEP 3 in 1 recall: Carotid stent and post-dilation balloon system with integrated embolic
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully…
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Class II · 1+ years ago
Philips North America Cardiac Workstation 7000 recall: Failure of Environmental Stress Testing from a pinched power module wire
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a…