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Endologix® Inc. Ovation iX Stent Graft system - recalled due to material weakness, United States

3 years ago •source www.fda.gov

Recall notice

United States

Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcement Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. All lots/serial numbers, not yet implanted, of the following models are in the scope of the correction:
Check the full recall details on www.fda.gov
Source: FDA

#medicaldevices #us

303

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Two drums that I just reported to you that I received and did not even order. They pulled my credit card off of my computer without my permission and I have no idea what credit card they use or anything. I have no idea what the things … See More
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Online Scam, 2800 North Franklin Road, Indianapolis, IN, USA

3 weeks ago •reported by user-jcbt2612

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Walmart Mainstays Electric Mini Choppers recalled due to Laceration Hazard, USA

3 weeks ago •source www.cpsc.gov

Recall notice

Walmart has issued a recall for over 51,750 units of its Mainstays Electric Mini Choppers due to a laceration hazard. The product, sold exclusively at Walmart, has a blade that can operate unexpectedly, posing a risk to consumers. The issue came to light after Walmart received five … See More
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The choppers were sold at Walmart stores nationwide and online from August 2022 through October 2023, priced between $10 and $15. The recalled product is the Mainstays Electric Mini Chopper with model number MS14100094536S1. These choppers are rechargeable and cordless, featuring a green lid, white body, and clear plastic bowl. They come with a single blade attachment, which includes three curved blades on a white plastic spindle. The model number can be found on the label attached to the bottom of the clear plastic bowl.

Consumers should immediately stop using the recalled choppers, and contact Walmart to receive a full refund. Consumers can bring the chopper to their nearest Walmart store for a refund.

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Source: www.cpsc.gov
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I recently purchased a walking pad via TikTok shop. In the past I’ve always received exactly what I’ve ordered. But not this time. Upon purchase, my checking account was charged $99 but yesterday to my surprise the only thing I received was a photograph of the item.

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