États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
CPSCAMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows and Infant Support Cushions; Sold on Amazon by Pretty-Life
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows and Infant Support Cushions; Sold on Amazon by Pretty-Life
The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows?and infant support cushions because they can obstruct an infant's breathing, posing a serious risk of injury or death from suffocation.
CPSCTopyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold by Jialyduu
Topyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold by Jialyduu
The recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
CPSCConair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
CPSCWinco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
The recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards.
CPSCCooper Lighting Recalls Metalux Optimized High Bay LED Light Fixtures Due to Fire Hazard
Cooper Lighting Recalls Metalux Optimized High Bay LED Light Fixtures Due to Fire Hazard
The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard.
NHTSANissan North America, Inc. - Rear Seat Belts May Not Secure Child Seat/FMVSS 208
Nissan North America, Inc. - Rear Seat Belts May Not Secure Child Seat/FMVSS 208
An improperly secured child restraint system may not restrain an occupant as intended, increasing the risk of injury during a crash.
NHTSAKia America, Inc. - Park Outside: Fire from Overheated Power Seat Motors
Kia America, Inc. - Park Outside: Fire from Overheated Power Seat Motors
A fire increases the risk of injury.
NHTSAJayco, Inc. - Grounding Connection Not Installed
Jayco, Inc. - Grounding Connection Not Installed
The electrical system may overheat without a ground, increasing the risk of a fire. There is also an increased risk of injury from electrical shock.
NHTSAJayco, Inc. - Grounding Connection Not Installed
Jayco, Inc. - Grounding Connection Not Installed
The electrical system may overheat without a ground, increasing the risk of a fire. There is also an increased risk of injury from electrical shock.
NHTSACrestline Coach Ltd. - Park Outside: Fuel Line May Leak and Cause Fire
Crestline Coach Ltd. - Park Outside: Fuel Line May Leak and Cause Fire
A fuel leak increases the risk of a fire.
NHTSAHyundai Motor America - Park Outside: High Voltage Battery May Catch Fire
Hyundai Motor America - Park Outside: High Voltage Battery May Catch Fire
A fire increases the risk of injury.
NHTSAKia America, Inc. - Park Outside: High Voltage Battery May Catch Fire
Kia America, Inc. - Park Outside: High Voltage Battery May Catch Fire
A fire increases the risk of injury.
FDA DevicesMedline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
FDA FoodSpring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC 850055470019, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Spring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC 850055470019, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Potential Salmonella contamination
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA FoodJoy Mint Lassi 16 oz.
Joy Mint Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesThuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.
FDA FoodJoy Plain Chaash Lassi 16 oz., 64 oz.
Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA DevicesDa Vinci ASSY, PSS, SP1098, Part Number: 380601
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
FDA DevicesINZONE DETACHMENT SYSTEM, REF: M00345100950
INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
FDA DevicesOctopus 4 Tissue Stabilizer, Model 29400
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA FoodMotor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
potential salmonella contamination
FDA Food5# Sunflower Seeds C/S
5# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.