Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesThe product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
FDA FoodEL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190204 Item: 102279
EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190204 Item: 102279
Undeclared milk.
FDA FoodSALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Product may be contaminated with Salmonella.
FDA DevicesMedline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA DevicesMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ0842873L LEFT HEART DYNJ45984J LIPO PACK DYNJ87218 MAA Y90 TRAY DYNJ82191D MAIN OR CATH LAB DYNJ61373B MINIMALLY INVASIVE PACK-LF DYNJ0843063M NEURO CERVICAL PACK DYNJ0101287M NEURO RADIOLOGY RICHMOND DYNJ68365F NEURO VP SHUNT PACK-LF DYNJ0843121L NON-VASCULAR PACK DYNJ56386C, DYNJ56386D OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B OR RADIOLOGY PACK DYNJ62747A PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C PICC ABSCESS PACK-LF DYNJ0774005I PICC TRAY DYNJ30554I PODIATRY PACK DYNJ46333G POSTERIOR SPINE PACK-LF DYNJ0843339P RRMC ANGIO PACK DYNJ36338D SPECIAL PROCEDURE PACK DYNJ88258 VASCULAR ACCESS PACK-LF DYNJ0101291G VASCULAR HYBRID DYNJ57543K VASCULAR PACK DYNJ82220D VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M WPH EP PACK DYNJ62745A
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ0842873L LEFT HEART DYNJ45984J LIPO PACK DYNJ87218 MAA Y90 TRAY DYNJ82191D MAIN OR CATH LAB DYNJ61373B MINIMALLY INVASIVE PACK-LF DYNJ0843063M NEURO CERVICAL PACK DYNJ0101287M NEURO RADIOLOGY RICHMOND DYNJ68365F NEURO VP SHUNT PACK-LF DYNJ0843121L NON-VASCULAR PACK DYNJ56386C, DYNJ56386D OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B OR RADIOLOGY PACK DYNJ62747A PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C PICC ABSCESS PACK-LF DYNJ0774005I PICC TRAY DYNJ30554I PODIATRY PACK DYNJ46333G POSTERIOR SPINE PACK-LF DYNJ0843339P RRMC ANGIO PACK DYNJ36338D SPECIAL PROCEDURE PACK DYNJ88258 VASCULAR ACCESS PACK-LF DYNJ0101291G VASCULAR HYBRID DYNJ57543K VASCULAR PACK DYNJ82220D VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M WPH EP PACK DYNJ62745A
Unapproved design changes to the products outside of the 510(k) clearance.
FDA DevicesThe product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
FDA DevicesMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
Unapproved design changes to the products outside of the 510(k) clearance.
FDA DevicesOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
FDA DevicesAccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (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.
NHTSALode-King Industries, Ltd. - Insufficient Rear Impact Protection/FMVSS 223
Lode-King Industries, Ltd. - Insufficient Rear Impact Protection/FMVSS 223
A guard with inadequate strength may not sufficiently protect a following vehicle, increasing the risk of injury during a rear end crash.
NHTSAJayco, Inc. - The Water Heater May be Missing the Mixing Valve
Jayco, Inc. - The Water Heater May be Missing the Mixing Valve
The water could reach scalding temperatures without the mixing valve, increasing the risk of injury.
NHTSAHarley-Davidson Motor Company - Pressurized Crankcase May Eject Oil
Harley-Davidson Motor Company - Pressurized Crankcase May Eject Oil
When the dipstick is removed while the crankcase is pressurized, oil may eject from the fill spout, increasing the risk of injury.
NHTSAFord Motor Company - Loose Bolt in Front Seat Frame
Ford Motor Company - Loose Bolt in Front Seat Frame
A seat with a dislodged bolt may not properly restrain an occupant in a crash, increasing the risk of injury.
NHTSAAmerican Battery Solutions Inc. - High Voltage Battery Contactor Failure May Cause Loss of Drive Power
American Battery Solutions Inc. - High Voltage Battery Contactor Failure May Cause Loss of Drive Power
A loss of drive power can increase the risk of a crash.
NHTSAShyft Group - Incorrect GVWR on Certification Label
Shyft Group - Incorrect GVWR on Certification Label
Referencing the incorrect GVWR may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
NHTSAVolkswagen Group of America, Inc. - Seat Belts May Not Restrain Occupants
Volkswagen Group of America, Inc. - Seat Belts May Not Restrain Occupants
Improperly restrained occupants have an increased risk of injury during a crash.
NHTSAGeneral Motors, LLC - Sediment in Brake Fluid/FMVSS 116
General Motors, LLC - Sediment in Brake Fluid/FMVSS 116
Sediment in brake fluid may reduce brake performance, increasing the risk of a crash.
NHTSAREV Recreation Group - Park Outside: Generator May Turn On Unexpectedly
REV Recreation Group - Park Outside: Generator May Turn On Unexpectedly
A generator that operates in an enclosed space, such as a garage, increases the risk of injury or death from carbon monoxide poisoning.
CPSC32 Degrees Recalls Heated Socks Due to Burn Hazard
32 Degrees Recalls Heated Socks Due to Burn Hazard
When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard including burns.
NHTSAJaguar Land Rover North America, LLC - Fuel Tank May Leak
Jaguar Land Rover North America, LLC - Fuel Tank May Leak
In the event of a crash, an improperly manufactured fuel tank may leak fuel, increasing the risk of a fire.
CPSCTzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to Serious Injury from Impact Hazard
Tzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to Serious Injury from Impact Hazard
Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard.
CPSCCpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Violates Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
Cpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Violates Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
CPSCChildren's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by TOETOL HOME
Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by TOETOL HOME
The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
NHTSAVolvo Trucks North America - Rear Brake Modulators May Short Circuit
Volvo Trucks North America - Rear Brake Modulators May Short Circuit
A loss of anti-lock brakes and electronic stability control increases the risk of a crash or injury.