Ultradent Products, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0053-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 31, 2020

Date Posted: October 14, 2020

Recall Number: Z-0053-2021

Event ID: 86432

Reason for Recall:

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Status: Terminated

Product Quantity: 412 syringes (206 kits)

Code Information:

Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated