CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
PermaFlo Flowable Composite recalled by Ultradent Products
Ultradent Products is recalling PermaFlo Flowable Composite, distributed nationwide in the US. The recall was initiated on 31 Aug 2020 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-0053-2021
- FDA event ID
- 86432
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2020
- FDA classified
- 2 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 31 Aug 2020 | Recall initiated by company | |
| 2 Oct 2020 | Classified by FDA | +32 days |
| 14 Oct 2020 | 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
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Product as listed by the FDA
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMontanaNorth CarolinaNew Jersey
Questions about this recall
Is PermaFlo Flowable Composite recalled?
Yes. Ultradent Products recalled PermaFlo Flowable Composite on 31 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0053-2021.
Why was it recalled?
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Which lots are affected?
Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
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 Ultradent Products
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Jiffy Original Composite Polisher Cups (Coarse) recalled | Ultradent Products | Device Malfunction | 31 states |
| Device | CLASS II | Vit-l-escence Singles A3 recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Singles Universal Body (UB) Refill recalled | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Peak Universal Bond Self-Etch Bottle Kit, Part recalled | Ultradent Products | Other | Nationwide |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |