Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
CPSCSDADI Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Yiwushi Bihe Trading
SDADI Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Yiwushi Bihe Trading
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
CPSCNoerishia Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Hurzein
Noerishia Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Hurzein
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
NHTSAChrysler (FCA US, LLC) - Steel Wheels May Crack and Separate
Chrysler (FCA US, LLC) - Steel Wheels May Crack and Separate
Loss of vehicle control increases the risk of a crash.
NHTSAJaguar Land Rover North America, LLC - Water May Damage Rearview Camera
Jaguar Land Rover North America, LLC - Water May Damage Rearview Camera
A rearview camera image that does not display can decrease the driver's visibility, increasing the risk of a crash.
CPSCWarren James Recalls the Copper Cup Found in Flashgitz Relic Lunch Boxes Due to Risk of Serious Injury or Death from Lead Poisoning
Warren James Recalls the Copper Cup Found in Flashgitz Relic Lunch Boxes Due to Risk of Serious Injury or Death from Lead Poisoning
The cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning hazard. Lead is toxic if ingested by adults or children and can cause adverse health issues.
NHTSAInternational Motors, LLC - Battery Cable May Short Circuit
International Motors, LLC - Battery Cable May Short Circuit
A short circuit increases the risk of a fire.
NHTSAAltec Industries, Inc. - Unprotected Boom Stow Wire May Short and Cause Fire
Altec Industries, Inc. - Unprotected Boom Stow Wire May Short and Cause Fire
An overheated wire can ignite flammable material in the cargo area, increasing the risk of fire.
CPSCTOMY Recalls Boon PIVOT Collapsible Toddler Tower Kitchen Step Stools Due to Risk of Serious Injury and Death from Tip-Over and Fall Hazards
TOMY Recalls Boon PIVOT Collapsible Toddler Tower Kitchen Step Stools Due to Risk of Serious Injury and Death from Tip-Over and Fall Hazards
The recalled toddler towers can tip over while in use, posing a risk of serious injury and death, due to tip over and fall hazards.
CPSCTarget Recalls Cat & Jack Children's Sandals Due to Risk of Serious Injury or Death from Choking Hazard
Target Recalls Cat & Jack Children's Sandals Due to Risk of Serious Injury or Death from Choking Hazard
The sandals' decorative pearls can fall off, posing a risk of serious injury or death from a choking hazard.
CPSCHuish Outdoors Recalls Hollis Diving Regulators Due to Risk of Serious Injury or Death from Drowning
Huish Outdoors Recalls Hollis Diving Regulators Due to Risk of Serious Injury or Death from Drowning
The regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.
CPSCOitnlaughter Projecting Finger Light Toys Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by Delightmi
Oitnlaughter Projecting Finger Light Toys Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by Delightmi
The recalled finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
CPSCPanasonic Recalls Electric Toaster Ovens Due to Shock and Fire Hazards
Panasonic Recalls Electric Toaster Ovens Due to Shock and Fire Hazards
The power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posing a risk of shock and/or fire hazard.
FDA FoodAlabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box
Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box
Foreign material: small metal pieces
FDA DrugsPemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Lack of Sterility Assurance
FDA DrugsMethohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Failed Impurities/Degradation Specifications
FDA DrugsDrogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Subpotent drug
FDA FoodVanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen
Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen
Undeclared Allergen (Soy)
FDA DrugsDrogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Subpotent drug
FDA DevicesBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
FDA DrugsGasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Subpotent drug
FDA DevicesOlympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
FDA DevicesAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness).
FDA DevicesMedline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
FDA DevicesTMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.