Stryker Corporation recalls STRYKER PKG.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 35 recalls
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility.…
Due to nonconforming products being inadvertently distributed.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected.…