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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.