Complete FDA and NHTSA recall records dated in 2025, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and…
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
IV sets may leak.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Wound dressing may have foreign matter on the product.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
