CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
Sunstar Butler Clear Dip recalled by Sunstar Americas
Sunstar Americas is recalling Sunstar Butler Clear Dip. The recall was initiated on 23 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1382-2021
- FDA event ID
- 87600
- Recalling firm
- Sunstar Americas, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2021
- FDA classified
- 9 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Mar 2021 | Recall initiated by company | |
| 9 Apr 2021 | Classified by FDA | +17 days |
| 21 Apr 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be contaminated with Burkholderia contaminans.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Where it was distributed
US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
Questions about this recall
Is Sunstar Butler Clear Dip recalled?
Yes. Sunstar Americas recalled Sunstar Butler Clear Dip on 23 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1382-2021.
Why was it recalled?
Product may be contaminated with Burkholderia contaminans.
Which lots are affected?
Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039
Where was it sold?
US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sunstar Americas
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Butler Clear Dip/case recalled by Sunstar Americas | Sunstar Americas | Other | Nationwide |
| Device | CLASS II | Sunstar G.U.M Perioshield Oral Health Rinse recalled by Sunstar Americas | Sunstar Americas | Sterility | Nationwide |
| Device | CLASS II | Sunstar G.u.m recalled by Sunstar Americas | Sunstar Americas | Sterility | Nationwide |
| Drug | CLASS II | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 12%, Alcohol Free recalled | Sunstar Americas | Sterility | Nationwide |
| Drug | CLASS I | Paroex (chlorhexidine gluconate) Oral Rinse, USP 12%, Alcohol Free recalled | Sunstar Americas | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |