Medical Devices Recalls

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Tritanium Patella Inserter Instrument fracture during implantation. .

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.

Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.

Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

LED battery chargers may prematurely fail and will not charge the LED battery as intended

Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.