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Olympus Insufflation Units Recalled by FDA Due to Software Issues

The FDA has classified a recall of Olympus High Flow Insufflation Units (models UHI, UHI-2, UHI-3) as Class I due to a software issue that could lead to overpressure events, potentially causing serious injury or death. Olympus is removing these discontinued devices from the market, and users are instructed to immediately cease usage and quarantine affected units.

Urgent Enforcement Medical Devices
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FDA Early Alert: Abiomed Heart Pump Purge Cassette Issue

The FDA issued an Early Alert regarding a potentially high-risk issue with Abiomed's Impella Purge Cassettes and Pump Sets. The issue involves an increased risk of purge leaks in Generation 1 Purge Cassettes, which could lead to pump stops and patient death. Abiomed has recalled affected products, and four serious injuries have been reported.

Urgent Notice Medical Devices
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Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.

Urgent Enforcement Medical Devices
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Go Raw LLC Recalls Cat Food Due to Low Thiamine

Go Raw LLC is voluntarily recalling one lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets due to low thiamine levels. The recall was initiated after one report of illness in a cat, which has since recovered. Consumers are advised to stop feeding the product and return it for a refund.

Urgent Enforcement Food Safety
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Made Fresh Salads Recalls Cream Cheese for Listeria Contamination

Made Fresh Salads, Inc. is recalling assorted flavors of cream cheese due to potential contamination with Listeria monocytogenes. The recall was initiated after the company's own sampling revealed contamination from a mixer. No illnesses have been reported to date.

Urgent Enforcement Food Safety
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Saputo USA Recalls Great Value Cottage Cheese Due to Health Risk

Saputo USA is recalling Great Value cottage cheese sold at Walmart due to potential under-pasteurization, posing a health risk. The FDA is aware of the recall, which affects products distributed in multiple states. Consumers are advised to return affected products for a refund.

Urgent Enforcement Food Safety
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Elite Treats Recalls Chicken Chips for Salmonella Contamination

Elite Treats, LLC. is recalling a single lot of chicken dog treats due to potential Salmonella contamination. The recall impacts products sold to feed stores in Alabama, Florida, Georgia, North Carolina, and South Carolina. No illnesses have been reported to date.

Urgent Enforcement Food Safety
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Lockout Supplements Recalls Chocolate Syrup for Undeclared Sildenafil

Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup nationwide due to undeclared sildenafil. The undeclared ingredient poses a risk of dangerous blood pressure reduction when interacting with prescribed medications.

Urgent Enforcement Food Safety
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DOJ requires Reddy Ice to divest assets for Arctic Glacier acquisition

The Department of Justice's Antitrust Division requires Reddy Ice and Arctic Glacier to divest assets in five states to proceed with their acquisition. This action aims to preserve competition for packaged ice sold to retail chains, airlines, and airline caterers, preventing potential price increases and service quality decreases.

Priority review Enforcement Antitrust & Competition
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Executive Pleads Guilty to Bid-Rigging Conspiracy Affecting US Military

The Department of Justice announced that Thomas C. Rollins, president of a metal fabrication company, pleaded guilty to a conspiracy to rig bids for contracts affecting US military installations. The conspiracy generated over $8.5 million in rigged procurements.

Urgent Enforcement Antitrust & Competition

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