SunTech Medical Disposable (Suntech) – mislabeled product (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Brand
Suntech Medical, Inc.
Lot Codes / Batch Numbers
Catalog # 98-0400-98 Lot Number: A4H201
Products Sold
Catalog # 98-0400-98 Lot Number: A4H201
Suntech Medical, Inc. is recalling SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 due to Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
Recommended Action
Per FDA guidance
On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.
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 noticePage updated: Jan 10, 2026