Dixtal Medical, Inc. Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.
Brand
Dixtal Medical, Inc.
Lot Codes / Batch Numbers
Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.
Products Sold
Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.
Dixtal Medical, Inc. is recalling Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam due to Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.
Recommended Action
Per FDA guidance
Urgent Product Recall Notification was issued to affected accounts by email/facsmile on May 8, 2009 requesting to cease distribution, quarantine and return recalled product. Contact Dixtal Medical with questions; to inquire about your on-hand inventory; or to arrange to receive replacement product at Customer Service: sales@dixtal.com, Phone Number 1-203-269-1112, Fax Number 1-203-269-1760.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, TX
Page updated: Jan 10, 2026