FDA Medical Device Recalls (openFDA)
Sunstar Americas, Inc.: SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
- Recall number
- Z-1382-2021
- Recalling firm
- Sunstar Americas, Inc.
- Product
- SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
- Status
- Terminated
- Initiated
- 2021-03-23
- Posted
- not on file
- Terminated
- 2023-08-28
- Reason
- Product may be contaminated with Burkholderia contaminans.
- Root cause
- Process control
- Action
- Sunstar initiated the recall by letter and email on 03/23/2021. The letter requested the consignee check their inventory and isolate affected product, then contact customer service with the results. The firm requested the return of the product. Distributors are asked to notify their customers down to the user level.
- Quantity
- 19471 bottles
- Distribution
- US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
- Lot, serial or model codes
- Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EAX
- Firm FEI
- 1413787
- Firm city
- Schaumburg
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28