The FDA has posted 35 enforcement recalls from Stryker Corporation since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
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.…
Firm name as filed with the FDA: “Stryker Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.