Overview of recall records associated with Covidien, LP, including dates, categories and classifications where available.
Classification mix: Class II: 72, Class I: 26.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could…
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted…
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted…
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in…
This page summarizes recall records in which the official source identifies Covidien, LP as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
