Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Non_Dehp Extenstion Set recall: IV sets may leak
IV sets may leak.
-
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…
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Extension SET recall: IV sets may leak
IV sets may leak.
-
Class II · 1+ years ago
Baxter Healthcare Corporation Continu-Flo Solution Set, Non-Vented recall: IV sets may leak
IV sets may leak.
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Paclitaxel Set recall: IV sets may leak
IV sets may leak.
-
Class II · 1+ years ago
American Contract Systems Inc. Medical convenience kits Ihdc30R D AND C Pack 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…
-
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…
-
Class II · 1+ years ago
Kico Knee Innovation Company Brand Name: Arvis Product Name: Arvis" Shoulder Model/ recall: Complaint identified issue with AI surgical planning software that may result
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Non-Dehp Continu-Flo Soln SET, 96" recall: IV sets may leak
IV sets may leak.
-
Class II · 1+ years ago
Boston Scientific Corporation LGX 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.
-
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…
-
Class I · 1+ years ago
Boston Scientific Corporation Proponent 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…
-
Class I · 1+ years ago
Evis Exera II Bronchovideoscope Olympus BF Type P180 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…
-
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.
-
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…
-
Class II · 1+ years ago
Boston Scientific Corporation 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.
-
Class II · 1+ years ago
Diagnostica Stago, Inc. Product: STA Liatest D-Di recall: A potential risk of underestimation of D-Dimer (D-Di) levels with the two
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
-
Class I · 1+ years ago
Evis Exera III Bronchovideoscope Olympus BF-H190 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…
-
Class I · 1+ years ago
Percussionaire Corporation Phasitron 5, IPV In-Line Valve recall: IFU update; in-line valve, with pressure relief seal may leak when used
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes…
-
Class I · 1+ years ago
Bronchofiberscope Olympus BF Type PE2 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…
-
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…
-
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…
-
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…
-
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…