Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 805–816 of 816 recalls
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.