I Am Reporting, YOSHI DEALS
3 weeks ago •reported by user-jhnw1745
Hi I received a ring GRA that I didn’t order
Philips pressure and mechanical ventilator devices - recalled due to health risks, USA
2 years ago •source www.fda.gov
Recall notice
United States
Company name: PhilipsBrand name: Philips
Product recalled: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Reason of the recall: Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
FDA Recall date: June 15, 2021
Recall details:
- Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies
- Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
- Philips aims to address all affected devices within the scope of this correction as expeditiously as possible.
Amsterdam, the Netherlands – Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.
To date, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.
Therefore, Philips has decided to voluntarily issue a recall notification* to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
Recall notification* advise for patients and customers. Based on the latest analysis of potential health risks and out of an abundance of caution, the recall notification* advises patients and customers to take the following actions:
- For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*
- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*
Possible health risks: The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues.
Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.
The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.
*This is a recall notification for the US only, and a field safety notice for the rest of the world
**Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.
Check the full recall details on www.fda.gov
Source: FDA
303
Recent Interesting Reports
Received product I did not order, Kanosh, UT, USA
2 weeks ago •reported by user-vmrj9634
Today I received a package that I did NOT place. It was for OzemPill. We know we did not place the order. We document all orders we make.. The package did not have a receipt with it, so there is no record of the alleged date when
…
the order was placed and sent. There is no record of price or even how it was charged.
Any help as to how and why this happened would be helpful and also how to return
Tamara K.
Any help as to how and why this happened would be helpful and also how to return
Tamara K.
ForeverMen Natural Energy Boost - recalled due to undeclared allergens, USA
3 weeks ago •source www.fda.gov
Recall notice
FAonline INC, is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the
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ForeverMen products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall. ForeverMen was distributed to consumers nationwide via the Internet. To date, Happy Together Inc. has not received any reports of adverse events related to this recall.
Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.
The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count box. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. FAonline INC. is notifying its customers that have the ForeverMen products to stop use and properly discard the product.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: FAonline Inc
Brand name: ForeverMen
Product recalled: Natural Energy Boost
Reason of the recall: Product is tainted with sildenafil and tadalafil
FDA Recall date: April 02, 2024
Source: www.fda.gov
Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.
The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count box. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. FAonline INC. is notifying its customers that have the ForeverMen products to stop use and properly discard the product.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: FAonline Inc
Brand name: ForeverMen
Product recalled: Natural Energy Boost
Reason of the recall: Product is tainted with sildenafil and tadalafil
FDA Recall date: April 02, 2024
Source: www.fda.gov
303
Heather's Motty, 2207 Summit Avenue, Union City, NJ, USA
2 weeks ago •reported by user-gftfm286
I have received 2 different packages from Heather's Motty which I did NOT order. I will admit that I had looked at the product but because of my resent weight loss I wasn't sure of the size I should get so I never actually order this product,
…
however have received 2 separate orders. What can I do to return and receive my money back?
2.8K
Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance, USA
2 weeks ago •source www.fda.gov
Recall notice
Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good
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manufacturing practice (cGMP) requirements. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.
The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.
- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.
- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651
Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.
Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.
Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024
Source: www.fda.gov
The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.
- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.
- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651
Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.
Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.
Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024
Source: www.fda.gov
303
I keep getting these pills from Nutra and I haven’t ordered them, I’m located in Houston, Texas, and this package is coming from Tampa Florida
1 week ago •reported by user-hhtx5714
I’m receiving these pills. I have no idea what they are or where they came from and they’re charging me $50 on my credit card. I don’t know how to send them back.
I received a package from heather mottys, Hudsonville, Michigan, USA
3 weeks ago •reported by user-bjwg9873
I received an order from Heather's motty. It wasn't at all what I ordered. No receipt, no way to return.
That does not look at all what I ordered. How do I return and get a refund
That does not look at all what I ordered. How do I return and get a refund
73
Unordered Package, Florida, USA
2 weeks ago •reported by user-pcnz8334
I received 8 little black shoe shine sponges from Heather's Motty in Union City, NJ 07087
269
I received a package that I didn't order, the Name on the package is VERDI Bioribose, Tampa, FL, USA
3 weeks ago •reported by user-txfph166
I don't know what happened, All I know is I received an email from my credit union last week asking me if I ordered anything online, and I told them no, and then this week I get this package. The bubble envelope says Fullfillment House PO Box 5708 Tampa FL 33675
522
a package I did not order, Boscobel, WI, USA
3 weeks ago •reported by user-hqjf6546
I received a package I did not order from
Rosewood P
2800 N Frankin Rd
Indianapolis, IN 46219
ugly black necklace inside the package
Rosewood P
2800 N Frankin Rd
Indianapolis, IN 46219
ugly black necklace inside the package
5
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