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Non-ablative Laser System WFB-01 (WINGDERM) – Software Bug (2024)

Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

Low

FDAAug 23, 2024Nationwide• WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China

Pecan Blend (Flagstone Foods) – Undeclared Almonds (2024)

Undeclared Allergen

Undeclared Almonds. The firm was notified by their customer that the product contains undeclared almonds.

Class IIModerate

FDAAug 23, 2024DE, MD, MA +6 more

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Non-ablative Laser System WFB-01 (WINGDERM) – Software Bug (2024)

Pecan Blend (Flagstone Foods) – Undeclared Almonds (2024)

54th St Blackened Sauce (La Fontanella) – Missing Soy Statement (2024)

BIOTROL PURIT Cleaner (Young Dental) – Bacterial Contamination (2024)

MultiDiagnost Eleva (PHILIPS) – Cable Hose Carrier Risk (2024)

Tirzepatide Injection (ProRx) – Sterility Concern (2024)

Azurion System (PHILIPS) – Cable Hose Carrier Risk (2024)

StealthStation S8 App (Medtronic) – Procedural Anomalies (2024)

INTEGRIS Allura System (PHILIPS) – Cable Hose Carrier Risk (2024)

KINOVA Jaco Assistive Robot (Kinova) – Fire Hazard (2024)

Moringa Butter Murukku (Sri Lakshmi Narasimhar) – Undeclared Milk (2024)

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Millet Butter Karasev (Sri Lakshmi Narasimhar) – Undeclared Milk (2024)

Ragi Butter Murukku (Sri Lakshmi Narasimhar) – Undeclared Milk (2024)

Blueberry Scones (Skagit River Bakery) – Undeclared Soy (2024)

Marionberry Scones (Skagit River Bakery) – Undeclared Soy (2024)

Millet Butter Murukku (Sri Lakshmi Narasimhar) – Undeclared Sesame Milk (2024)

Curry Leaves Butter Murukku (Sri Lakshmi Narasimhar) – Undeclared Milk (2024)

Tirzepatide Multidose (ProRx) – Sterility Concern (2024)