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Articles Tagged with product recall

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The headquarter of Philips in AmsterdamThe situation involving Philips and its decision to halt the sale of new sleep therapy and respiratory care devices in the U.S., as part of a consent decree with the FDA, raises serious concerns from a product liability perspective. This move, necessitated by significant quality issues that led to a massive recall of over 15 million devices, underscores a critical lapse in Philips’ quality control and regulatory compliance mechanisms. The revelation of such extensive quality problems not only erodes consumer trust but also exposes Philips to substantial legal and financial risks.

The consent decree, while a step toward remediation, highlights a reactive rather than proactive approach to product safety. The necessity for such an agreement reflects a failure in Philips’ internal processes to ensure the safety and efficacy of their products before they reach consumers. The impact of these failures is not trivial, considering the potential health risks to users of sleep therapy and respiratory care devices. Such situations demand rigorous scrutiny, as they can lead to severe health consequences for individuals relying on these medical devices for critical care.

The financial implications of the recall and the consent decree, including a significant provision of 363 million euros, indicate the scale of the impact on Philips’ operations. However, beyond the financial toll, there’s a broader consideration regarding the damage to the company’s reputation and the potential erosion of trust among healthcare providers and patients. This trust is paramount in the healthcare sector, where the stakes involve patient health and safety.

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defective-evo-ventilatorRecent recalls by Philips have highlighted the importance of product liability and patient safety in the healthcare sector. The latest recall involves approximately 57,000 Evo ventilators due to issues with the machines’ air flow sensors.

Philips’ Respironics unit has faced a series of recalls since 2021, initially related to soundproofing foam used in its sleep apnea devices and ventilators. The Evo ventilator, designed for hospital and professional care settings, is now undergoing its second Class I recall in recent months. The recent recall, labeled as Class I by the U.S. Food and Drug Administration (FDA), highlights the severity of the issue.

Reasons for Recall

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16 people were injured after a defective pedal on their peloton bike broke. Five of them required medical care such as stiches in their lower leg.  Peloton Interactive, Inc. a New York based company, received so far 120 complaints of defective pedal and announced on October 15 that it was recalling the PR70P Clip-In Pedals fitted on Peloton bikes  which were sold between July 2013 and May 2016. The potentially defective pedal has a orange logo and the name Peloton is printed in white letters next to it.  It was manufactured in Taiwan. While Peloton recommend consumers change their pedals every year, consumers who bought the PR70P Clip-In Pedals are being notified directly by the company that will let them know how they can receive free pedals with accompanying instructions on how to install them.

5,700 defective Extension Cord Splitters sold by Homerygardens at Walmart and Amazon.com recalled the same day

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person-holding-hand-sanitizer-396233175 dangerous hand sanitizers that are being sold at major retailers such as CVS, Wallmart and others have been recalled by the FDA. The dangerous products contained methanol, also known as wood alcohol. When absorbed by the skin or swallowed, methanol can lead to severe injury such as blindness neurological damage or even death. The FDA has received several reports of consumers including children who suffered personal injury or died  after being exposed to these dangerous products.

Please check your hand sanitizer  and make sure it is not part of the list released by the FDA.

Some of the products recalled were sold under the following brands: Good Gel, Lavar 70, Saniderm, CleanCare, All-Clean and Eskbiochem. All these brands are manufactured by the same Mexican company Eskbiochem SA de CV.

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dangerous sleeper recalledThe Fisher Price rock’n play sleeper is dangerous as babies not only can roll over when unrestrained but they can also suffocate or die from strangulation. A recent investigation by Consumer Reports found that at least 32 babies died in accidents that occurred while they were resting in the Rock’n Play sleeper. A few days after the investigation was published, Fisher Price announced that it was recalling all 4.7 million Rock and Play sleepers.

Rock’n Play sleepers are inclined padded sleepers that automatically rock the babies to put them asleep. The product requires the baby to be inclined on its back and to be restrained which the American Academy of Pediatrics (AAP) doesn’t recommend. Safe sleep guidelines from the AAP recommend that babies be put in their bed alone on their back on a firm flat mattress, free form soft bedding.

Positional Asphixia

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Defective Hoverboard Lazy BoardDespite the many fire accidents and injuries caused by defective lithium-ion battery packs in hoverboards, the toy remains among the most popular holiday gifts. If you or your kids own a self balancing scooter or if you are planning to buy one as a gift you should visit the Consumer  Product Safety Commission website and check on the recent Self Balancing Scooter recalls. Here are some of the most recently recalled models:

  • The Layz Board hoverboard was recently the subject of a second warning by the Consumer Product Safety Commission. According to the agency this hoverboard caused a fire on October 23, 2017, in Manchester Township, Pennsylvania, which destroyed one town home and damaged four others. The hoverboard was the object of a previous warning in May 2017 after two young girls died in a house fire caused by the Layz Board hoverboard on March 10, 2017, in Harrisburg, Pennsylvania
  • Salvage World just recalled 700 Smart Balance Wheel self-balancing Scooters/Hoverboards. The battery can overheat and pose a risk of smoking, exploding or catching fire
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defective Tic Tac Toe GameA defective child product was recalled Today by Target. If you recently bought the Magnetic Tic Tac Toe Game you should be aware that this game set is defective and extremely dangerous for your children. The magnets can detach from the game pieces and pose a chocking hazard. Additionally if a child swallows more that one magnet, the magnet can attach together and create serious injuries such as intestinal obstructions, perforations, sepsis and death.

If you owned this game (see picture)  stop using it immediately and contact Target for a refund.

Read more on the CPSC website

 

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Defective sterilization process may have caused contamination in some Bumble Bee and Chicken of the Sea tuna cans. Contaminated products may potentially cause life threatening illnesses. According to CNN, the quality and compliance team discovered a malfunction OF a machinery part during the sterilization process during a routine inspection in a Georgia production plant in which both brands were manufacturing their products. The malfunction may have caused some products to be not fully cooked.

The recall affects 31,579 cases of Bumble Bee canned tuna with UPC codes codes 8660000020, 8660000021 and 8660000736 sold nationally in February 2016. The recalls also affects 2,745 cases of Chicken of the Sea brand with UPC codes are 0 4800000195 5 and 0 4800000245 7 and produced last February and March.

Bumble Bee product recall

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Defective front disk brakes and quick-release levers installed on 1.3 million bicycles in the US may pose a risk of injury to bicycle riders. An open quick release lever on the bicycle’s front wheel hub can come into contact with the front disc brake rotor causing the front wheel to come to a sudden stop or separate from the bicycle. Therefore the following companies are recalling some models from the following brands:

bike recall

If your bicycle is from one of these brands, the video below can help you determine if your bicycle is affected  and if so what to do about it.

 

 

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A defective surgical staple used to close tissue in the left atrial appendage of the heart is being recalled by the FDA after reports that patients suffered personal injuries such as tissue tears and bleeding  including a possible tear of the left atrial wall (top left chamber) during use of the device.   The manufacturer of the defective medical device, Maquet Medical Systems, sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers asking them to immediately remove and quarantine the Tiger paw System II from their inventory.

Read the press release from the FDA