Covidien Recalls

Hazard: Sterilization method used was not consistent with the labeling and the approved sterilization method

Hazard: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

Hazard: Potential for the sterile packaging to be compromised

Hazard: The product was released into commercial distribution while subject to importation refusal.

Hazard: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Hazard: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Hazard: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Hazard: Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation

Hazard: This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.

Hazard: The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.

Hazard: The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: Potential for product sterility breach due to a compromised or pinched seal defect

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Hazard: Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Hazard: Potential proplylene glycol contamination

Hazard: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.

Hazard: There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

Hazard: There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

Hazard: Product reportedly shutting down during use.

Hazard: Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.