The FDA has posted 22 enforcement recalls of automated external defibrillators (non-wearable) devices 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 customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
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.
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Automated External Defibrillators (Non-Wearable)”). Informational only — verify against the FDA before acting.