The Recall Desk
HighFDA (Devices)·Z-0720-2022·Announced 2022-03-09

BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance

Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a product marketed without FDA premarket clearance. No illnesses or injuries have been reported. Under the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Sunstar Americas, Inc. is recalling BUTLER Clear Dip, a dental care product distributed nationwide in the United States. The product was marketed without obtaining the required premarket clearance from the U.S. Food and Drug Administration.

The recall involves 22,514 units of BUTLER Clear Dip (SKU 716P, 16oz bottles). Affected lot codes are: S350LP, S350LN, T116JA, T117JE, T187DH, T187DJ, and T263FD.

Consumers who have purchased this product should stop using it and dispose of it safely. For questions about this recall, contact Sunstar Americas, Inc. directly.

The recalled product

Product
BUTLER Clear Dip, 12 bottles/case
Manufacturer
Sunstar Americas, Inc.
Category
Medical Device — Dental Care
Hazard
  • unapproved-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • SKU 716P (Clear Dip 16oz)
  • Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD

Distribution

Distributed nationwide across the United States.

Related recalls

Same category