Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips 5-Lead Set Recalled by Philips North America, LLC Due to The thickness of the connector to the trunk...
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 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Quantity: 280 boxes ( 5600 leadsets)
Why Was This Recalled?
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
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