Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 62 recalls
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.
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.