FUJIFILM Healthcare Americas Corporation Recalls

Undeclared allergen - soy

Class II

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Moderate

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Turkeyfoot Creek Chocolate PB Ice Cream – undeclared soy (2025)

Undeclared allergen - soy

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Avalanche Ice Cream (Turkeyfoot Creek) - Undeclared Allergens (2025)

Undeclared allergens - soy and wheat

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Turkeyfoot Creek Cookie Dough Ice Cream – undeclared allergens (2025)

Undeclared allergens - soy and wheat

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Turkeyfoot Creek Cacao Brownie Bites – undeclared allergens (2025)

Undeclared allergens - soy and wheat

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Turkeyfoot Creek Cacao Strawberry Ice Cream – undeclared soy (2025)

Undeclared allergen - soy

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Turkeyfoot Creek Cacao Ice Cream – undeclared soy (2025)

Undeclared allergen - soy

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Cookies and Cream Ice Cream (Turkeyfoot Creek) - Undeclared Allergens (2025)

Undeclared allergens - soy and wheat

FDAJun 10, 2025IN, MI, OH• Turkeyfoot Creek Creamery LLC

Akreos Intraocular Lens (Bausch & Lomb) – Diopter Calculation Error (2025)

An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.

FDAJun 6, 2025AZ, CA• Bausch & Lomb Surgical, Inc.

Superion IDS Kit (Boston Scientific) – Performance Consistency Issue (2025)

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

FDAJun 6, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Shell Eggs (August Egg Company) - Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAJun 6, 2025AZ, CA, IL +6 more• August Egg Company

Custom Manifold Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

Window Air Conditioners (Midea) - Mold Exposure (2025)

This recall involves U and U+ Window Air Conditioners made by Midea and sold in brand names including Midea, Comfort Aire, Danby, Frigidaire, Insignia, Keystone, LBG Products, Mr. Cool, Perfect Aire and Sea Breeze. The air conditioners are designed to fit in windows. They were sold in three sizes of cooling power: 8,000, 10,000 and 12,000 BTU. The air conditioners are white and measure about 22 inches wide and 14 inches high. The brand name is printed on the units. The model number can be found on a label on the front right side of the unit when facing the air conditioner. They were sold with remote controls and can be controlled by a mobile app. The following brands and model numbers are included in this recall: Midea Model Numbers MAW08AV1QWT MAW08AV1QWT-C MAW08U1QWT MAW08V1QWT MAW08V1QWT-S MAW08V1QWT-T MAW08W1QWT MAW10U1QWT MAW10V1QWT MAW10W1QWT MAW12AV1QWT MAW12AV1QWT-C MAW12U1QWT MAW12V1QWT MAW12V1QWT-M MAW12V1QWT-S MAW12W1QWT Comfort Aire Model Numbers RXTS-101A RXTS-121A RXTS-81A Danby Model Numbers DAC080B6IWDB-6 DAC080B7IWDB-6 DAC100B6IWDB-6 Frigidaire Model Numbers GHWQ085WD1 GHWQ105WD1 GHWQ125WD1 Insignia Model Numbers NS-AC8WU3 NS-AC8WU3-C Keystone Model Numbers KSTAW08UA KSTAW10UA KSTAW12UA LBG Products Model Number QB-8K CO Mr. Cool Model Numbers MWUC08T115 MWUC10T115 MWUC12T115 Perfect Aire Model Numbers 1PACU10000 1PACU12000 1PACU8000 Sea Breeze Model Numbers MWAUQB-12CRFN8-BCN10 WAU310YREX WAU312YREX WAU38YREX

Moderate

CPSCJun 5, 2025Nationwide• GD Midea Air-Conditioning Equipment Co. Ltd., of China

Apollo Smoke and CO Detectors (Apollo America) – Alert Failure (2025)

Fire/Burn Risk

This recall involves Apollo America Combination Smoke and Carbon Monoxide Detectors with model number 51000-600. The recalled detector was sold in a white color. The front of the recalled detector has the text "Replace by" followed by a date ranging from 2034/June to 2034/October. "Apollo" and the model number 51000-600 are on the back of the detector. Note: If you choose to dispose of the detector's primary/non-rechargeable lithium battery, do not throw the battery in the trash, or in the general recycling stream (e.g., street-level or curbside recycling bins). Lithium batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center or battery recycling boxes found at various retail and home improvement stores may accept this lithium battery for disposal. Before taking your battery to a HHW collection center, contact that office ahead of time and ask whether it accepts lithium batteries. If it does not, contact your municipality for further guidance.

Very High

CPSCJun 5, 2025Nationwide• Apollo America Inc., of Auburn Hills, Michigan

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.