Recalls published in October 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in October 2025, newest first.
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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
Bronchovideoscope Olympus BF-1TQ170 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 I · 1+ years ago
Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D 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 II Bronchovideoscope Olympus BF Type Q180-AC 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 II · 1+ years ago
BioPro Femoral Head cobalt chromium and ceramic heads Part 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
Philips North America Cardiac Workstation 5000 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…
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Class I · 1+ years ago
Bronchovideoscope Olympus BF-1TH1100 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 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 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 II Bronchovideoscope Olympus BF Type 1T180 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
Ethicon Endo-Surgery Inc Echelon Linear Cutters Reload 80 mm Blue recall: The devices were shipped unsterilized
The devices were shipped unsterilized.
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Class II · 1+ years ago
BioPro Bipolar Head Product ID/Description 18130 Bipolar Head 38MM 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
Bronchovideoscope Olympus BF Type P150 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
Boston Scientific Corporation 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 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
Ferno-Washington Inc Ferno Power X2 Powered Ambulance COT, Model/ recall: The fastening post hardware could loosen allowing the fastening post
The fastening post hardware could loosen allowing the fastening post to detach from the cot
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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
Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD 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
OES Bronchofiberscope Olympus BF Type 1T60 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…