Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an Recalled by Philips North America, LLC Due to Internal Paddles may wear over time and may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America, LLC directly.
Affected Products
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.
Quantity: 21,683 Internal Paddle Sets.
Why Was This Recalled?
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America, LLC
Philips North America, LLC has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report