The FDA has issued a warning and recall for Hologic Inc.’s BioZorb Marker products, implantable devices used for marking soft tissues. This follows reports of serious adverse events, including pain, infection, and device migration. The recall mandates the return of all unused BioZorb devices and advises healthcare providers on managing existing implants.
Smiths Medical, a subsidiary of ICU Medical Inc., has issued a recall of its paraPAC plus P300 and P310 ventilators due to a potential safety issue with the patient outlet connector. The faulty connector could detach, leading to serious complications including respiratory arrest and death. One death and one injury have been reported. The recall comes after a previous recall of Smiths Medical tracheostomy tubes.
Medtronic has issued a recall for certain McGrath MAC and MAC EMS Video Laryngoscopes due to a potential battery explosion risk. The recall also includes updated instructions for other models. Separately, Baxter International is recalling certain components for its Volara System due to potential issues with the handset plug disconnecting from the ventilator adapter.
