TruAbutment Inc. recalls Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software…
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- TruAbutment Inc.
- Product
- Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software…
- Classification
- Class II
- Units
- US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2025-03-19
USPhilips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- US
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart…
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
FDA · DeviceZOLL Medical CorporationDomestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD,…Official notice → - US
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls COR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
FDA · DeviceDePuy Mitek, Inc., a Johnson & Johnson Co.Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil,…Official notice → - US
Aesculap Inc recalls Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps…
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
FDA · DeviceAesculap IncDistribution was made nationwide and to PR. There was also government/military…Official notice → - US
CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an…
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
FDA · DeviceCardioFocus, Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Czech…Official notice → - US
Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD…
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke…
FDA · DeviceMedtronic Perfusion SystemsDomestic distribution nationwide. International distribution to the following…Official notice →