États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesSoft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
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.
FDA FoodKirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRADITIONAL MADELEINES***INGREDIENTS: WHEAT FLOUR **EGGS, BUTTER (CREAM) ***ALLERGEN INFORMATION: CONTAINS WHEAT, EGG, MILK*** PRODUCED ON EQUIPMENT THAT ALSO PROCESSES PEANUTS, TREE NUTS AND SESAME***.
Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRADITIONAL MADELEINES***INGREDIENTS: WHEAT FLOUR **EGGS, BUTTER (CREAM) ***ALLERGEN INFORMATION: CONTAINS WHEAT, EGG, MILK*** PRODUCED ON EQUIPMENT THAT ALSO PROCESSES PEANUTS, TREE NUTS AND SESAME***.
Undeclared hazelnut and soy lecithin.
FDA DevicesSoft-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.
FDA DevicesSoft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 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.
FDA DevicesOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA DevicesLeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
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.
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.
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.
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.
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.
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.
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.
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.
NHTSAMack Trucks, Inc. - Rear Brake Modulators May Short Circuit
Mack Trucks, Inc. - Rear Brake Modulators May Short Circuit
A loss of anti-lock brakes and electronic stability control increases the risk of a crash or injury.
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.
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.
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.
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.
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.
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.
NHTSAChrysler (FCA US, LLC) - Instrument Panel Display Failure/FMVSS 108, 208
Chrysler (FCA US, LLC) - Instrument Panel Display Failure/FMVSS 108, 208
An instrument panel display that fails to show critical safety information, such as gear selection and warning lights, increases the risk of a crash.