Summary
The FDA issued a Class II for Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 by PYRAMES INC. Reason: Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood.
Details
Source
Device Recall
External ID
Z-1508-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Lot/Code Info: Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
Quantity Affected: 35
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.
Distribution
US distribution to states of: MA and CA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-24
Company
Cupertino, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PYRAMES INC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PYRAMES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PYRAMES INC have FDA actions?
PYRAMES INC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1508-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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