Boppli Blood Pressure Monitors Recalled for Detection Failures

Agency Publication Date: April 2, 2025

Summary

Pyrames Inc. is recalling 35 Boppli Bedside Device Kits and Sensor Bands used to monitor blood pressure in neonates and infants. The recall was issued because vibratory noise from other hospital equipment can prevent the device from accurately detecting changes in a baby's blood pressure. While no injuries have been reported, the manufacturer has provided specific setup instructions to ensure the device functions correctly until it can be returned or corrected.

Risk

Vibratory noise can interfere with the sensor, causing it to fail to detect critical changes in an infant's blood pressure. This could lead to a delay in medical treatment for vulnerable patients in neonatal or pediatric care.

What You Should Do

This recall involves the Boppli Bedside Device Kit (model 54-0002) and Sensor Band (model 51-0007) with software version 2.2.3. Check the product labels for these identifiers.
Identify if your device is affected by checking the lot numbers printed on the packaging: for the Bedside Device Kit, check for lots 24020902, 24040302, and 23103002; for the Sensor Band, check for lots 24011702 and 24111301.
Immediately ensure that ventilator lines do not touch the infant's isolette (including the mattress, side rails, or pillow) or the patient to reduce interference.
Move the affected Boppli monitor to the patient's foot.
Stop using the recalled product. Contact Pyrames Inc. or your distributor to arrange for a return, replacement, or correction of the device.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Boppli Bedside Device Kit

Variants: Software version 2.2.3

Model / REF:

54-0002

Lot Numbers:

24020902

24040302

23103002

UDI:

10860007282925

Single-use battery-powered blood pressure monitor for neonates and infants.

Product: Boppli Sensor Band

Variants: Software version 2.2.3

Model / REF:

51-0007

Lot Numbers:

24011702

24111301

UDI:

10860007282901

Single-use battery-powered blood pressure monitor component.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96414

Status: Active

Manufacturer: PYRAMES INC

Sold By: Direct to hospitals; Authorized clinical distributors

Manufactured In: United States

Units Affected: 35

Distributed To: Massachusetts, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Boppli Bedside Device Kit (model 54-0002) and Sensor Band (model 51-0007) with software version 2.2.3. Check the product labels for these identifiers.

Identify if your device is affected by checking the lot numbers printed on the packaging: for the Bedside Device Kit, check for lots 24020902, 24040302, and 23103002; for the Sensor Band, check for lots 24011702 and 24111301.

Immediately ensure that ventilator lines do not touch the infant's isolette (including the mattress, side rails, or pillow) or the patient to reduce interference.

Move the affected Boppli monitor to the patient's foot.

Stop using the recalled product. Contact Pyrames Inc. or your distributor to arrange for a return, replacement, or correction of the device.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Affected Products

Product: Boppli Bedside Device Kit

Variants: Software version 2.2.3

Model / REF:

54-0002

Lot Numbers:

24020902

24040302

23103002

UDI:

10860007282925

Single-use battery-powered blood pressure monitor for neonates and infants.

Product: Boppli Sensor Band

Variants: Software version 2.2.3

Model / REF:

51-0007

Lot Numbers:

24011702

24111301

UDI:

10860007282901

Single-use battery-powered blood pressure monitor component.