BlueStar Direct LLC Recalls

FDAAug 26, 2024IL• BlueStar Direct LLC

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

Class IIILow

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

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

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

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FDA

Aug 23, 2024

Nationwide

• Olympus Corporation of the Americas

Progressive Industries RSM-30 (PROGRESSIVE) – Ground Contact Issue (2024)

Navico Group is recalling certain Progressive RSM-30 and PSK-30 surge protectors, designed for use with recreational vehicles. The ground contact in the surge protector may not properly contact the mating ground pin, causing an open ground condition.

NHTSAAug 23, 2024Nationwide• PROGRESSIVE INDUSTRIES

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

Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

FDAAug 23, 2024Nationwide• Stryker Spine

Great Dane Everest SS (GREAT DANE) – Gear Mount Welding (2024)

Great Dane Trailers (Great Dane) is recalling certain 2025 Everest SS refrigerated trailers. The support gear bracing mounts may have been welded improperly.

NHTSAAug 23, 2024Nationwide• GREAT DANE

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

This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.

FDAAug 23, 2024MO• Princeton Biomeditech Corp

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

All model WLA-01 systems sold to US customers are found to have labeling non-compliances

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

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)

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.

FDAAug 23, 2024DE, MD, MA +6 more• Flagstone Foods LLC

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

Soy is in the ingredients but missing from the contains statement.

FDAAug 23, 2024KS• La Fontanella Food Products LLC

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

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

TRUBLUE Speed Auto Belay Devices (Head Rush) – Fall Risk (2024)

This recall involves Head Rush Technologies TRUBLUE Speed Auto Belay Devices, 12.5m and 16m versions. The device enables climbers to safely descend after a speed climbing event. The device is gray with blue handles, the 12.5m version has black webbing handgrip above the carabiner, and the 16m version has blue webbing handgrip. The model TRUBLUE Speed TBSD150-20 and serial number are on a label located on the handle. The auto belay devices have a serial number within the serial number range: TBSD00098 through TBSD01180.

Very High

CPSCAug 22, 2024Nationwide• Head Rush Technologies, of Louisville, Colorado

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

Undeclared Soy

Undeclared soy lecithin and soybean oil on label

FDAAug 22, 2024IN, WA• Skagit River Bakery & Cafe

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

Undeclared Soy

Undeclared soy lecithin and soybean oil on label

FDAAug 22, 2024IN, WA• Skagit River Bakery & Cafe

Forest River Salem (FOREST RIVER) – Tire Chassis Contact (2024)

Forest River, Inc. (Forest River) is recalling certain 2024-2025 Salem SBF325RL, and Wildwood WBF325RL travel trailers. The tires may contact chassis components, causing the tires to fail.

NHTSAAug 22, 2024Nationwide• FOREST RIVER

Forest River Wildwood (FOREST RIVER) – Tire Mounting Issue (2024)

Forest River, Inc. (Forest River) is recalling certain 2024 Forest River Salem, and Wildwood travel trailers. The tire may contact the outrigger, causing the tire to fail.

NHTSAAug 22, 2024Nationwide• FOREST RIVER

Allura Xper OR Table (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.