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Monarch Rollator Blue (Nova Ortho-Med) – Fall Hazard (2024)

Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.

Moderate

FDAAug 26, 2024Nationwide• Nova Ortho-Med Inc

Protein-Packed Power Waffles (Kodiak Cakes) – Soft Plastic Film (2024)

Foreign object - Soft plastic film

Class IIModerate

FDAAug 26, 2024IL, IN, IA +10 more• KODIAK CAKES LLC

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Monarch Rollator Blue (Nova Ortho-Med) – Fall Hazard (2024)

Protein-Packed Power Waffles (Kodiak Cakes) – Soft Plastic Film (2024)

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Endoscopic Flushing Pump (Olympus) – Function Loss Risk (2024)

AVS Anchor-C Cervical Cage System (Stryker) – Labeling Correction (2024)

Osom Ultra hCG Test (Princeton Biomeditech) – False Negative Risk (2024)

Diode Laser Hair Removal WLA-01 (WINGDERM) – Labeling Issue (2024)

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

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Tirzepatide Multidose (ProRx) – Sterility Concern (2024)

Tirzepatide Injection (ProRx) – Sterility Concern (2024)

Semaglutide Multiple Dose Vial (ProRx LLC) – Sterility Concern (2024)