Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
Missry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
The Misco Sports Badminton Toy Sets violate the mandatory safety standard for children's toys because the shuttlecocks contain button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and deaths.
CPSCZWILLING J. A. Henckels Aktiengesellschaft Recalls Electric Water Kettles Due to Risk of Serious Injury Due to Burn Hazard
ZWILLING J. A. Henckels Aktiengesellschaft Recalls Electric Water Kettles Due to Risk of Serious Injury Due to Burn Hazard
The kettle's handle can loosen and separate from the kettle, causing hot contents to spill, posing a risk of serious injury due to a burn hazard.
CPSCMinka Lighting Group Recalls Bardon Series Pendant Light Fixtures Due to Risk of Serious Injury or Death from an Impact Hazard
Minka Lighting Group Recalls Bardon Series Pendant Light Fixtures Due to Risk of Serious Injury or Death from an Impact Hazard
The recalled light fixture's frame can detach from the pendant downrod during installation, posing a risk of serious injury or death from an impact hazard.
CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard
Petzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard
The recalled harnesses are missing rivets in the FAST LT PIN-LOCK buckles, causing the buckles to open, posing a risk of serious injury or death from a fall hazard.
CPSCCosyland Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Cosyland Official
Cosyland Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Cosyland Official
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.
CPSCWorld Bright International Limited Recalls Agio Menlo Woven Patio Swings Due to Risk of Serious Injury or Death from Fall Hazard; Sold at Costco
World Bright International Limited Recalls Agio Menlo Woven Patio Swings Due to Risk of Serious Injury or Death from Fall Hazard; Sold at Costco
The swing seat can detach from the frame while in use, posing a risk of serious injury or death from a fall hazard.
FDA DevicesMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesMedline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesBrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
FDA DevicesDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesAurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
FDA DevicesMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesDEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DrugsbusPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Subpotent drug
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER 2 NEURO CART, Model Number: ACC010543; 7) DRAWER 4, Model Number: ACC010722; 8) SUCTION TRAY, Model Number: ACC010862; 9) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER 2 NEURO CART, Model Number: ACC010543; 7) DRAWER 4, Model Number: ACC010722; 8) SUCTION TRAY, Model Number: ACC010862; 9) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesMedical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
FDA DevicesERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
FDA FoodHatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339
Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA DevicesDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesHalyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DevicesDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.