Sunstar Americas, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1382-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

Product Classification:

Class II

Date Initiated: March 23, 2021

Date Posted: April 21, 2021

Recall Number: Z-1382-2021

Event ID: 87600

Reason for Recall:

Product may be contaminated with Burkholderia contaminans.

Status: Terminated

Product Quantity: 19471 bottles

Code Information:

Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039

Distribution Pattern:

US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico

Voluntary or Mandated:

Voluntary: Firm initiated