The FDA has posted 8 enforcement recalls from Physio-Control, Inc. since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intende…
Due to pediatric defibrillator electrode delamination
Due to required inspections not being performed on products/units that have gone through servicing.
Due to required inspections not being performed on products/units that have gone through servicing.
Due to required inspections not being performed on products/units that have gone through servicing.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Firm name as filed with the FDA: “Physio-Control, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.