Ultradent Products, Inc. recalls Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill,…
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Read the official notice →- Date
- 2022-07-20
- Country
- United States
- Brand
- Ultradent Products
- Product
- Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of Florida,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ultradent Products recalls
- 2026-04-08
USUltradent Products, Inc. recalls Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
FDA · DeviceUltradent Products, Inc.US: MA, WI, ME, AL, NY, MN, CA, KY, IL, WY, WA, OH, PR, CT, OR, NJ, MI, NC,…Official notice →- 2024-09-18
- US
Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A…
Due to a manufacturing issue, red particulates present in the expressed composite.
FDA · DeviceUltradent Products, Inc.US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-20
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or…
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
- US
Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for…
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- US
Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
FDA · DeviceInvacare CorporationDomestic distribution to the following states: ALASKA ARIZONA CALIFORNIA…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿…
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Colombia, India,…Official notice → - US
Wright Medical Technology, Inc. recalls Wright EVOLVE TRIAD Plate Cutter, REF 49510120
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
FDA · DeviceWright Medical Technology, Inc.Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto…Official notice → - US
Draeger Medical Systems, Inc. recalls Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
FDA · DeviceDraeger Medical Systems, Inc.No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT,…Official notice →