Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesPhilips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA DevicesPhilips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA DrugsLevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Labeling: Missing Label
FDA DevicesiLet Bionic Pancreas, REF: BB1001
iLet Bionic Pancreas, REF: BB1001
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
FDA DevicesBoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
FDA DevicesBrand 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.
NHTSAShyft Group - Incorrect Cargo Carrying Capacity on Label
Shyft Group - Incorrect Cargo Carrying Capacity on Label
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
NHTSATesla, Inc. - Rearview Camera Image May Not Display/FMVSS 111
Tesla, Inc. - Rearview Camera Image May Not Display/FMVSS 111
A delayed rearview image reduces the driver's view behind the vehicle, increasing the risk of a crash.
NHTSAWinnebago Industries, Inc. - Incorrectly Routed LP Hose May Cause Fire
Winnebago Industries, Inc. - Incorrectly Routed LP Hose May Cause Fire
Heat exposure may damage the hose. A damaged hose may leak fuel, increasing the risk of a fire.
NHTSAGulf States Toyota, Inc. - Incorrect Load Carrying Capacity on Label/FMVSS 110
Gulf States Toyota, Inc. - Incorrect Load Carrying Capacity on Label/FMVSS 110
An incorrect load carrying capacity label may lead to improper loading of the vehicle, increasing the risk of a crash.
USDA FSISFSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
FSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
Mislabeling, Unreported Allergens
NHTSAMercedes-Benz USA, LLC - Blank Instrument Panel Display
Mercedes-Benz USA, LLC - Blank Instrument Panel Display
An instrument panel display that fails to show critical safety information, such as the speedometer and warning lights, increases the risk of a crash.
NHTSABraun Corporation - Rear Bench May Be Missing Seat Legs
Braun Corporation - Rear Bench May Be Missing Seat Legs
An incomplete seat may not properly restrain an occupant, increasing risk of injury during a crash.
NHTSANew Flyer of America, Inc. - Speedometer May Fail to Illuminate/FVMSS 101
New Flyer of America, Inc. - Speedometer May Fail to Illuminate/FVMSS 101
An unlit speedometer cannot show the vehicle's speed, increasing the risk of a crash.
NHTSAWaymo LLC - ADS Software May Allow Vehicle to Drive onto a Flooded Roadway
Waymo LLC - ADS Software May Allow Vehicle to Drive onto a Flooded Roadway
Entering a flooded roadway can cause a loss of vehicle control, increasing the risk of a crash or injury.
NHTSAMercedes-Benz USA, LLC - Front Passenger Seat Belt May Not Fasten
Mercedes-Benz USA, LLC - Front Passenger Seat Belt May Not Fasten
A passenger who is unable to fasten their seat belt is not properly restrained, increasing their risk of injury in a crash.
CPSCBayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury or Illness from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Bayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury or Illness from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resistant nor bears the required labeling statement, posing a risk of serious injury or illness from poisoning, if the contents are swallowed by young children.
CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online
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. The bed rails also do not meet structural stability or retention strap requirements, posing a fall hazard. The bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard. In addition, the bed rails do not bear the required hazard warning labels.