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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
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
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Patient support table floor plate may be incorrectly installed.