FDA DeviceClass IINotable

FDA Recall: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016

Date: 2026-03-18
Brand: Physio-Control, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to pediatric defibrillator electrode delamination

Hazard

Due to pediatric defibrillator electrode delamination

Remedy

16,499 electrodes (US/OUS: 8327/8172)

View original recall →
Share:

Related Recalls

2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Milestone S.R.L.
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor,
WHILL, INC.