Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boppli: Bedside Device Kit Recalled by PYRAMES INC Due to Single-use battery-powered blood pressure monitor, for use on...
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 PYRAMES INC directly.
Affected Products
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Quantity: 35
Why Was This Recalled?
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
Where Was This Sold?
This product was distributed to 2 states: CA, MA
About PYRAMES INC
PYRAMES INC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report