95,038 total recalls in our database
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Manufacturing flaw in the sterile barrier system
Potential for iGUIDE to incorrectly monitor the 3D position.
Manufacturing flaw in the sterile barrier system
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Becton Dickinson & Company
Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)
Pega Medical
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Suntech Medical
Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Manufacturing flaw in the sterile barrier system
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Santanello Surgical
Lack of package integrity may compromise sterility
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
Unknown Manufacturer
Walkers can be damaged over time exposing sharp points and small parts, posing choking and laceration hazards to small children.
Unknown Manufacturer
The pajamas fail to meet the federal flammability standard for children's sleepwear that requires sleepwear to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.