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Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden

Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden Recalls

All product recalls associated with Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden.

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Recall Summary

Total Recalls

451

Past Year

Class I (Serious)

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 451 recalls

Nobel Biocare N1 TiUltra (Nobel) – Packaging Defect (2025)

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

FDAJan 10, 2025Nationwide• Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden

VasoView Hemopro 2 with Vasoshield (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

FDADec 9, 2024Nationwide• Maquet Cardiovascular, LLC

VasoView HemoPro 2 Vessel Harvesting System (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

1 234 5...23

Page 3 of 23Next

FDA

Dec 9, 2024

Nationwide

• Maquet Cardiovascular, LLC

Cartiva Synthetic Cartilage Implant (Cartiva) – potential hazards (2024)

Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.

FDAOct 31, 2024Nationwide• Cartiva, Inc

Acrobat SUV Stabilizer (Maquet) – Sterile Barrier Compromise (2024)

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

FDAOct 16, 2024Nationwide• Maquet Cardiovascular, LLC

Acrobat-i Vacuum Stabilizer (Maquet) – Sterile Barrier Compromise (2024)

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

FDAOct 16, 2024Nationwide• Maquet Cardiovascular, LLC

Acrobat-i Positioner (Maquet) – Sterile Barrier Compromise (2024)

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

FDAOct 16, 2024Nationwide• Maquet Cardiovascular, LLC

Vue PACS Viewer (Philips) – Calculation Errors (2024)

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

FDAOct 10, 2024Nationwide• Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel

El Gallo Azul Processed Cheese (Yucatan Products) – Non-English Labeling (2024)

Non-English labeling

Class IIModerate

FDASep 30, 2024OR• Yucatan Products dba Lorena Sandoval

VasoView HemoPro System (Maquet) – Silicone Detachment (2024)

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

FDASep 20, 2024Nationwide• Maquet Cardiovascular, LLC

Quantimetrix Urine Control Set (McKesson) – Packaging Temperature Risk (2024)

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.

FDASep 17, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Cadet Apex72 Electric Heaters (Glen Dimplex) – Potential Fire Risk (2024)

Fire/Burn Risk

This recall involves Glen Dimplex Americas' Cadet-branded Apex72 high wall electric heaters between 1200 and 1600 Watts. The fan-forced heaters have a white dust cover and are installed into walls a minimum of six feet off the ground. "Cadet," the model number, and the manufacturing date in DD-MM-YY format appear on the rating label visible through the bottom of the air outlet grill. The following models and manufacturing dates are included in this recall: Models Manufacturing Dates HW128 01-Mar-21 through 29-Feb-24 HW132 01-Mar-21 through 29-Feb-24 HW151 01-Mar-21 through 29-Feb-24 HW162 any date older than 01-Mar-24 HW162BP5 any date older than 01-Mar-24 HW168 any date older than 01-Mar-24 HW168BP5 any date older than 01-Mar-24

CPSCSep 12, 2024Nationwide• Glen Dimplex Americas Ltd., of Vancouver, Washington

GE Giraffe Warmer (GE HealthCare) - Electrical Safety Gap (2024)

GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

GE Panda iRES Warmer (GE HealthCare) - Electrical Safety Gap (2024)

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

Proton Therapy System (IBA) – Positioning System Issue (2024)

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

FDAJul 10, 2024IL, LA, MI +6 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium

FRT250 Cartridge (Pega Medical) – Incorrect Component (2024)

During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

FDAJul 4, 2024Nationwide• ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL 1111 Chomedey (A-13) E Laval Canada

DVOT Multi-Pathogen Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

VASOVIEW HEMOPRO 2 Vessel Harvesting System (Maquet) – C-Ring Wire Problem (2024)

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

FDAMay 31, 2024Nationwide• Maquet Cardiovascular, LLC