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Found 12,723 results for "product recalls and alerts"
Lulujo Fish Sleepsuit 1.0 TOG recalled due to flammability hazard
Lulujo Fish Sleepsuit 1.0 TOG recalled due to flammability hazard
Flammability hazard
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Health Canada warns that Gedsffati Plug-in Combined Smoke and Carbon Monoxide Alarm previously available on Amazon.ca may fail to operate
Health Canada warns that Gedsffati Plug-in Combined Smoke and Carbon Monoxide Alarm previously available on Amazon.ca may fail to operate
Unauthorized products
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Due to complaints of device breakage at the traction force gauge to handle joint.
Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893
Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893
product tested positive for Listeria Monocytogenes.
52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7
52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42124 4
52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42124 4
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
TGA warning on the risks of importing unapproved peptide products
TGA warning on the risks of importing unapproved peptide products
We are warning consumers about the risks of importing and using unapproved peptide products that are promoted online....
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Galerie au chocolat brand plant based chocolate products recalled due to improperly declared milk
Galerie au chocolat brand plant based chocolate products recalled due to improperly declared milk
Milk
NANÖ Green Children’s Bathrobe recalled due to flammability hazard
NANÖ Green Children’s Bathrobe recalled due to flammability hazard
Flammability hazard
Magnetic Cube recalled due to ingestion hazard
Magnetic Cube recalled due to ingestion hazard
Ingestion hazard
FSIS Issues Public Health Alert for Various Meat and Poultry Products Containing FDA-Regulated Dairy Products That Have Been Recalled Due to Possible Salmonella Contamination
FSIS Issues Public Health Alert for Various Meat and Poultry Products Containing FDA-Regulated Dairy Products That Have Been Recalled Due to Possible Salmonella Contamination
Product Contamination
Malker Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by MalkerDirect

Malker Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by MalkerDirect
The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle lights do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
Nebulous Star brand children's dressing gowns and ponchos recalled due to flammability hazard
Nebulous Star brand children's dressing gowns and ponchos recalled due to flammability hazard
Flammability hazard
Stephan Baby Boo Bunnie and Friends Children’s Toys recalled due to choking and injury hazards
Stephan Baby Boo Bunnie and Friends Children’s Toys recalled due to choking and injury hazards
Choking hazard - Injury hazard
Qumeney Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Smfanlus

Qumeney Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Smfanlus
The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle lights do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
Build-A-Bear Workshop Heartwarming Hugs Bear 2 recalled due to choking hazard
Build-A-Bear Workshop Heartwarming Hugs Bear 2 recalled due to choking hazard
Choking hazard
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.