Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 829–840 of 845 recalls
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Potential for internal blood leaks due to cracked polyurethane
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
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.