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Cosmetics
Updated: May 27, 2022 11:00 AM
Henkel Corporation (“Henkel”) is voluntarily recalling 180 bottles of its 4.2 ounce Alterna Bond Repair Leave-in Heat Protection Spray, because it has the potential to be contaminated with Burkholderia cepacia complex (Bcc), which poses little medical risk to healthy people, but can cause an increased risk for... See More illness or infection in people who have certain health problems, such as weakened immune systems, chronic lung diseases, chronic granulomatous disease, or wound infections. Henkel has received no reports of harm or injury in connection with this product.
Patients with underlying lung disease (especially cystic fibrosis) might be at increased risk for severe infections with Bcc. The potential for product contamination was noted after testing performed by Henkel revealed the presence of Bcc in some 4.2 ounce bottles of Alterna Bond Repair Leave-in Heat Protection Spray.
The Alterna Bond Repair Leave-in Heat Protection Spray included in this recall comes in a 4.2 ounce, purple plastic spray bottle marked with lot # Y401427403 on the bottom, and was distributed nationwide through a distributor. The product was available for sale to the public no earlier than April 12, 2022.
The consumers who have purchased the applicable 4.2 ounce bottles of Alterna Bond Repair Leave-in Heat Protection Spray described above are urged to return them to their place of purchase for a full refund.
Consumers with questions about this recall may contact Henkel's customer specialists at 1-888-4ALTERNA (1-888- 425-8376). This customer service line is operational Monday through Thursday from 6:00 a.m. to 4:00 p.m. PST, and Friday from 6:00 a.m. to 2:00 p.m. PST.
If you have experienced any symptoms, or have any medical questions associated with this product, it is important to report it. It can help to prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Henkel Corp.
Brand name: Alterna
Product recalled: Leave-in heat protection spray
Reason of the recall: Potential to be contaminated with Burkholderia cepacia complex.
FDA Recall date: May 27, 2022
Source: fda.gov See Less
303
Babyganics is voluntarily recalling two lots of 20-ounce bottles of babyganics® 20oz chamomile verbena bubble bath, due to the presence of the bacterium Pluralibacter gergoviae. The products were sold in the last two months only at select retailers in the U.S.
During internal testing related to product... See More shelf life across the Babyganics bubble bath line, it was discovered that two specific lot numbers of this product contained the bacterium. While infants may be more susceptible than adults, Pluralibacter gergoviae does not usually cause healthy individuals to become sick. However, it may pose a risk of infection to those who are immunocompromised or have broken or irritated skin, such as diaper rash.
The only products affected are babyganics® 20oz chamomile verbena bubble bath UPC 8 13277 01375 4 with lot codes Y314 and Y315 found at the bottom of the packaging and contained in a white plastic bottle with a green plastic lid.
The testing confirmed that no other Babyganics products contained this bacterium. Babyganics takes pride in its commitment to vigorous consumer safety standards and providing peace of mind for parents, which is why the decision was made to voluntarily recover these bottles from retailers and to proactively reach out to consumers. Consumers with the affected product will be provided with a full refund after submitting their product and contact information at the company website. Consumers who have come into contact with the affected product and aren’t feeling well should contact their doctor.
Company name: Babyganics
Brand name: Babyganics
Product recalled: Chamomile verbena bubble bath
Reason of the recall: Presence of the bacterium Pluralibacter gergoviae, a bacterium
FDA Recall date: April 20, 2022
Source: fda.gov See Less
303
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Kao USA conducts voluntary recall of Jergens® Ultra Healing Moisturizer, issued 11-Mar-2022 by Kao USA Inc. over PR Newswire, the company advised that in the 'IDENTIFYING THE AFFECTED PRODUCTS' section, two lot codes have been added to the 3 oz size section ("ZU722861" and "ZU722871"). The complete,... See More corrected release follows: Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product.
Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections. Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure. Further investigation to determine the scope of the issue is still ongoing.
The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer. Only specific lots of the 3 oz and 10 oz sizes are affected.
IDENTIFYING THE AFFECTED PRODUCTS Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted.
The affected lot codes for the 3 oz size can be found on the back of the bottle printed in black ink and begin with the prefix "ZU":
ZU712851 ZU712911
ZU712861 ZU722851
ZU712871 ZU722881
ZU712881 ZU722861
ZU722871
The affected lot codes for the 10 oz size can be found on the bottom of the bottle printed in black ink and begin with the prefix "ZU":
ZU722741 ZU732791
ZU722771 ZU732801
ZU722781 ZU732811
ZU732781 ZU732821
Brand name: Jergens
Product recalled: Ultra Healing Moisturizer
Reason of the recall: Presence of Pluralibacter gergoviae, a bacterium
FDA Recall date: March 23, 2022
Company name: Kao USA Inc.
Source: fda.gov See Less
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Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product. Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a... See More bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections.
Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure. Further investigation to determine the scope of the issue is still ongoing. However, Kao USA Inc. promptly took the precautionary step of issuing a voluntary recall of the affected product by removing the product in question from warehouses, working with retailers to ensure the product is removed from store shelves, and proactively notifying consumers.
The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer. Only specific lots of the 3 oz and 10 oz sizes are affected.
IDENTIFYING THE AFFECTED PRODUCTS:
- Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted.
- The affected lot codes for the 3 oz size (UPC 019100109971 for single bottles and 019100267114 for pack of 3) can be found on the back of the bottle printed in black ink and begin with the prefix "ZU": ZU712851 | ZU712871 | ZU712911 | ZU722881 | ZU712861 | ZU712881 | ZU722851
- The affected lot codes for the 10 oz size (UPC 019100109988) can be found on the bottom of the bottle printed in black ink and begin with the prefix "ZU": ZU722741 | ZU722781 | ZU732791 | ZU732811 | ZU722771 | ZU732781 | ZU732801 | ZU732821
Anyone who has product from a recalled lot should call the Kao USA Inc. Consumer Care Center. A postage paid label and plastic bag will be sent to consumers via mail to easily return the product.
Company name: Kao USA Inc.
Brand name: Jergens
Product recalled: Ultra Healing Moisturizer
Reason of the recall: Presence of Pluralibacter gergoviae, a bacterium
FDA Recall date: March 18, 2022
Source: fda.gov See Less
305
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Company name: Becca Cosmetics
Brand name: Becca Cosmetics
Product recalled: Light Shifter Brightening Concealer
Reason of the recall: Potential Mold
FDA Recall date: May 07, 2020
Recall details: Company Announcement Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca... See More Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation.
To date, no adverse reactions or injuries have been reported. This product was manufactured in the United States and distributed nationwide. The below are the details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.
- Product Name: Becca Cosmetics Light Shifter Brightening Concealer
- Batch: 0030A, 9308A, 0052A, 0052C, 9291A, 9309A, 0036A, 0037A, 0038A, 0038B, 0041A, 9289A, 0062A, 0062B, 0062C, 9283A, 9284A, 9287A, 9288A
- Size: 3.2 mL (only size available)
- Product Description: Concealer wand with silver overlay, and a white secondary carton
- UPC: 9331137030037, 9331137030044, 9331137030051, 9331137030068, 9331137030075, 9331137030099, 9331137030082, 9331137030105
If you have this product, please stop using it and contact the place of purchase regarding a refund. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less
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Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.
Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.
The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.
Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.
Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.
In case you experience harm from this product, 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: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024
Recall link of December 2023: jnjmedtech.com
Source: fda.gov See Less
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