🏥 Medical Devices • 4,262 recalls
Lumenis Limited
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
Becton, Dickinson and Company, BD Biosciences
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
Windstone Medical Packaging
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Stryker Howmedica Osteonics
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Contour Fabricators
Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.
Natus Medical Incorporated
NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.
Circulatory Technology
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Baxter Corporation Englewood
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Spacelabs Healthcare
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
Siemens Medical Solutions USA
Software upgrade to eliminate several issues
Software patch installation to address several safety issues.
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Siemens Medical Solutions USA
Software patch installation to address several safety issues.
The Anspach Effort
There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
Siemens Medical Solutions USA
Software patch installation to address several safety issues.