FDA Medical Device Recalls (openFDA)
Sunstar Americas, Inc.: BUTLER Clear Dip, 12 bottles/case
- Recall number
- Z-0720-2022
- Recalling firm
- Sunstar Americas, Inc.
- Product
- BUTLER Clear Dip, 12 bottles/case
- Status
- Terminated
- Initiated
- 2022-01-14
- Posted
- not on file
- Terminated
- 2023-08-28
- Reason
- Product lacks premarket clearance.
- Root cause
- No Marketing Application
- Action
- A Recall Letter is being sent to all direct consignees who have received impacted product via USPS First Class mail The Recall Letter will be posted to the corporate web site at www.gumbrand.com Customers are instructed as follows: 1. Please examine your inventory to determine if you have any of the affected product lots 2. Please call 1-800-528-8537 or email: us.pcr@us.sunstar.com with the results of your inventory check (even if the affected lots are no longer in inventory), and if affected lots are present, provide the lot numbers, quantities, and a recall contact. 3. Complete the enclosed Return Response Form and mail, FAX or email the completed form as per the instructions provided. 4. The recalling firm will issue a call tag via UPS for any affected inventory to be returned 5. Upon receipt of the call tag return any affected products to the recalling firm 6. Because this recall is being initiated to the dental office level, the recalling firm asks that consignees also notify any parties to which you have further distributed the product.
- Quantity
- 22514 ea
- Distribution
- United States Nationwide distribution.
- Lot, serial or model codes
- SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OCT
- 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