🔍 RecallPedia

Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

Class I - Dangerous
🏥 Medical Devices Recalled: February 24, 2025 PYRAMES Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PYRAMES INC
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

Product Codes/Lot Numbers:

Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

Distribution:

Distributed in: US, MA, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1508-2025