FDA Medical devices recall ·
Boppli: Bedside Device Kit recall
- Recall number
- Z-1508-2025
- Date
- (initiated February 24, 2025)
- Company / brand
- Pyrames Inc
21730 Stevns Crk Blvd Ste 201a, Cupertino, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
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
US distribution to states of: MA and CA
States: California Massachusetts
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1508-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.