Z-0720-2022Class II

BUTLER Clear Dip, 12 bottles/case

Name: Z-0720-2022 BUTLER Clear Dip, 12 bottles/case
Creator: Sunstar Americas, Inc.
Published: 2022-01-14
License: https://open.fda.gov/license/

Sunstar Americas, Inc. / initiated 2022-01-14 / Terminated

FDA source

Sunstar Americas, Inc. began a recall of BUTLER Clear Dip, 12 bottles/case on 2022-01-14. FDA classified it as Class II and gives the reason as "Product lacks premarket clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0720-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-14
Posted: 2022-03-03
Terminated: 2023-08-28
Recalling firm: Sunstar Americas, Inc.
Product: BUTLER Clear Dip, 12 bottles/case
Product code: OCT Anti Fog Solution And Accessories, Endoscopy
Reason for recall: Product lacks premarket clearance.
FDA 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: [email protected] 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 in commerce: 22514 ea
Distribution: United States Nationwide distribution.
Product codes and lots: SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0720-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-03

Product code OCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)